Weekend Update

Rx coverage

Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, OPM, Patient safety, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The Hill reports,
    • “The Supreme Court is in its final sprint.
    • “President Trump’s agenda is on the line as the justices dash to hand down their remaining decisions by their self-imposed deadline of the end of June. 
    • “With 20 argued cases left, the court’s pace is exactly on par with this time last term. 
    • “But among those remaining cases are potentially seismic decisions on birthright citizenship, presidential firing power, transgender athletes, mail ballots and more. 
    • “The next opinions are expected Thursday.”
  • FedScoop reports,
    • “The Trump administration is already trying to bring talent from industry into the government via its U.S. Tech Force program, but the next step could be putting federal workers on exchanges to companies, according to remarks from an Office of Personnel Management official Thursday.
    • “During a panel at a federal technology-focused conference, Kevin Hennecken, senior advisor to the director at OPM and leader of the Trump administration’s Tech Force hiring effort, mentioned the agency’s interest in such a program as a way of helping train federal workers. 
    • “Something OPM has been focused on is “creating more pathways for people to sort of experiment going to the private sector for periods of time and coming back,” Hennecken said. “I think that can also be quite helpful, just to expose them to some different ways of getting things done.”
  • Per a June 11, 2026, HHS news release,
    • “The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), today announced $40 million in funding opportunities for eight grant programs that will advance President Trump’s Great American Recovery Initiative by preventing addiction, strengthening the behavioral health workforce, and supporting efforts to address mental illness and prevent suicide.”

From the Food and Drug Administration front,

  • Fox Business reports,
    • “The Food and Drug Administration (FDA) has classified a recall of more than 900 cases of Alfredo sauce at its highest risk level after a supplier recalled a dry milk powder ingredient used in the product due to potential salmonella contamination.
    • The FDA designated the recall as a Class I event, its most serious classification, meaning there is a reasonable probability that use of or exposure to the product could cause serious adverse health consequences or death.
    • The recall affects 913 cases of Alfredo sauce packaged in 3-pound, 7-ounce sealed poly bags and 12 bags per case, according to an FDA enforcement report.
  • STAT News relates,
    • “The Food and Drug Administration on Friday approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. 
    • “The drug was selected to go through a speedy review program launched last year by former FDA Commissioner Marty Makary, but the agency missed its goal date of April 21 to deliver a decision.” * * *
    • “Teplizumab, or Tzield, is a monoclonal antibody that aims to delay the progression of type 1 diabetes. The FDA first approved the drug to delay the onset of stage 3 diabetes in adults, and in children ages 8 and older with stage 2 disease. In April, the FDA expanded that approval to allow children as young as 1 year old to take the medication.
    • “The FDA cleared the drug under the accelerated approval pathway based on the surrogate endpoint of higher C-peptide levels. Sanofi will have to verify and describe clinical benefits for type 1 diabetes patients in follow-up studies.” 

From the judicial front,

  • Fierce Healthcare reports,
    • “On the heels of a legal challenge from CVS, Express Scripts has also sued to challenge Tennessee’s new pharmacy benefit management law.
    • “Under the law, PBMs would be barred from also owning pharmacies in the state. In its complaint, Express Scripts says that policy would not just impact retail pharmacies but would force its parent company, Evernorth, to shutter an Accredo specialty pharmacy center based in Memphis.
    • “Closing that facility, the company said, could cost thousands of jobs. And broadly speaking, the law could lead to pharmacy deserts in rural areas, where more than a third of its residents currently live.
    • “It could also limit access to home delivery services, the PBM said. Express Scripts Pharmacy shipped more than 2 million prescriptions to people in the Volunteer State last year alone.
    • “Other services that could be impacted by the law include fertility pharmacies, through which Express Scripts affiliates supported thousands of Tennesseans, the company said.
    • “Express Scripts argues that “shortsighted law” is unconstitutional and cannot be enforced, according to an announcement.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “A relentless measles outbreak in Utah has been spreading for nearly a year, putting the U.S. on a path to losing the measles-elimination status it earned more than two decades ago. 
    • “Fueling the nearly 12-month outbreak: more parents opting not to vaccinate their children for school; infections hitting communities statewide; and lenient public-health policies on quarantining exposed students.
    • “Utah’s streak of 679 cases is the latest and longest-lasting of a series of measles outbreaks in the U.S. since early last year. The Centers for Disease Control and Prevention is in the process of assessing whether any outbreaks lasted more than 12 months, which is a determinant of whether the U.S. would lose its status as a country that eliminated measles as of 2000.
    • “State health officials suspect there has been continuous spread since at least August. Utah’s outbreak has proved trickier to stop than other recent streaks of measles cases.” 
  • Medscape tells us,
    • “In adults with obesity and without diabetes, using GLP-1s vs other antiobesity medications was significantly associated with a decreased risk for osteoporosis, major osteoporotic fractures, degenerative disk disorders, and osteoarthritis.” * * *
    • “GLP-1s are uniquely positioned to achieve sustained weight loss without compromising — and possibly enhancing — bone integrity. They may be particularly suitable for individuals with preexisting risk factors for osteoporosis or degenerative joint disease, in whom other obesity agents may exacerbate skeletal fragility. Incorporating bone health assessment into obesity management may aid in optimizing therapeutic selection and improving comprehensive patient care,” the authors wrote.”
  • Healio informs us,
    • “At 2 years, crinecerfont demonstrated favorable effects on weight, body composition and insulin resistance in adults with classic congenital adrenal hyperplasia, researchers reported at ENDO 2026.
    • “In addition, crinecerfont (Crenessity, Neurocrine Biosciences) was associated with stable or improved bone age progression in children and adolescents with classic congenital adrenal hyperplasia (CAH), according to results from another ENDO 2026 presentation.”
  • and
    • “In patients with obesity, exercise as assessed by wearable-measured activity declined after they initiated GLP-1 receptor agonist therapy, according to findings presented at ENDO 2026.
    • “GLP-1 receptor agonists are now used by millions of adults for weight loss, and we know from prior work that exercise is critical for preserving lean muscle and sustaining long-term weight reduction,” Sajana Maharjan, MD, from the department of internal medicine at HSHS St. John’s Hospital in Springfield, Illinois, told Healio. “What was missing was an objective answer to a basic question: Do patients actually become more active as they lose weight on these drugs? Most prior studies relied on self-reported activity. The NIH All of Us Research Program, which links electronic health records with Fitbit data, gave us a chance to answer that question with wearable-measured activity in the same patients before and after starting therapy.” * * *
    • “Exercise needs to be actively prescribed alongside GLP-1 therapy, not assumed to follow from weight loss,” Maharjan told Healio. “Practically, that means structured exercise counseling at the time of initiation, a strong emphasis on resistance training to protect lean muscle, and physical therapy or pain management referrals for patients with joint or muscle pain. Our findings also suggest that men may need more targeted support, since they showed the steepest declines. Wearables themselves can play a useful role in tracking progress and keeping activity goals in front of patients over time. GLP-1 medications reduce not only fat but also lean muscle mass, which makes maintaining physical activity even more important during treatment. Patients who lose weight without staying active risk losing strength and function alongside the fat loss they came in for.”
  • and
    • “In patients being treated for hypertension, those taking a GLP-1 receptor agonist had higher rates of hypotensive events compared with those not taking one, researchers reported at ENDO 2026.
    • “I began to notice multiple patients in clinic who were started on GLP-1s (by me and others) who were complaining of lightheadedness, dizziness and fainting. They had low blood pressure on my examination,” Micah J. Eimer, MD, associate chief medical officer in the division of cardiology at Northwestern Medicine, told Healio. “Hypotension is the most dreaded potential side effect of treating hypertension and actually far more dangerous. The results were confirmatory to our clinical suspicion.” * * *
    • “Eimer told Healio that “blood pressure needs to be monitored in patients who are taking GLP-1s at the initiation of therapy and during dose escalation. Patients should also be warned about signs of low blood pressure so that they can report them. I am particularly worried about the risk to patients who obtain GLP-1s without direct and ongoing clinical supervision.”
  • The Wall Street Journal point out,
    • “New research indicates the brain can truly multitask by rewiring its circuitry with practice.
    • “A study in the Journal of Cognitive Neuroscience showed participants’ brains could automate tasks by offloading them from the prefrontal cortex to the temporal cortex.
    • “Automation requires extensive repetition, making effortful tasks easier and less attentionally demanding, study co-authors said.”
  • Per Fierce Pharma,
    • “In a plenary session at the 2026 European Hematology Association (EHA) annual meeting in Stockholm, Johnson & Johnson brought to the world stage a reminder of its status as a leading developer of multiple myeloma treatments. 
    • “The company spotlighted results from its MonumenTAL-3 phase 3 study, which added its GPRC5D bispecific antibody, Talvey, to the mainstay melanoma drug Darzalex Faspro in patients with relapsed or refractory multiple myeloma who had tried at least one prior line of therapy. When used with or without Bristol Myers Squibb’s Pomalyst (pomalidomide), the regimen cut the risk of disease progression or death by up to 72% and proved a clinically meaningful reduction of up to 53% in the risk of death compared with standard Darzalex Faspro, Pomalyst and dexamethasone (DPd), J&J said in a June 13 press release. 
    • “The trial showed a progression-free survival rate of up to 81.3% for the Talvey combos after 24 months compared with the standard-of-care regimen’s 51.2%, and an overall survival rate of up to 89.2% compared with 79.1% for DPd.”

From the U.S. healthcare business,

  • The Wall Street Journal reports on the future of healthcare technology.
    • “New scientific advances are poised to shift healthcare toward earlier disease prediction and prevention within the next five to 10 years.
    • “Blood tests, AI tools, and GLP-1 drugs are emerging for early detection and prevention of Alzheimer’s and heart disease.
    • “New therapies aim to regenerate damaged joints for arthritis and detect breast cancer recurrence earlier using circulating tumor DNA.”
  • MedCity News relates,
    • “Ascendiun CEO Paul Markovich recently launched a national policy reform movement called Worthy. During an interview at AHIP 2026, he shared four key policy efforts that Worthy is promoting.
      • “1. Digital health records: Markovich is proposing getting every American a comprehensive, real-time digital health record that can personalize their care. He said this would save over $300 billion in administrative costs throughout the system. Much of the healthcare system is currently run on outdated technology and fax machines.
      • “2. Change the way healthcare is paid for: The healthcare industry needs to transition to paying for outcomes versus the fee-for-service model.
      • “3. Make prescription drugs affordable: The price of pharmaceutical drugs has been growing at levels that aren’t sustainable for the public, Markovich said. He called for efforts to ensure intermediaries aren’t rewarded for selling a higher volume of more expensive drugs.
      • “4. Put the healthcare system on a budget: Markovich is calling for putting healthcare organizations on a budget and implementing financial consequences for missing budget targets. He argued that hospitals, in particular, are paid more to do more, incentivizing them to conduct more tests, scans, keep people overnight, etc. This eventually leads to more inflation. Instead, Markovich proposes reimbursing hospitals a fixed amount on a monthly basis and adjusting it for the risk of the population and the size of the population.”
  • and
    • “Rocket Pharmaceuticals sold its rare disease pediatric priority review voucher for $180 million, cash that the company will use to support a pipeline now led by a gene therapy in development for a rare, inherited disease with no FDA-approved therapies.
    • “Rocket announced the voucher sale on Friday. The Cranbury, New Jersey-based gene therapy developer did not disclose who purchased the voucher, saying only in a regulatory filing that the buyer was “a large pharmaceutical company.”
    • “The FDA awarded the voucher in March alongside the accelerated approval of Rocket’s Kresladi, the first gene therapy for leukocyte-adhesion deficiency type 1 (LAD-1), an inherited immunodeficiency that can become fatal to babies. Such vouchers may be applied to another eligible rare disease therapy, cutting the standard 10-month review down to six months. But vouchers are transferable and many recipients choose to sell them.”
  • A commentator observes in MedCity News,
    • “In the Age of AI, Interoperability Isn’t Enough: Why Healthcare Needs Shared Understanding, Not Just Shared Data.”
    • ‘The industry needs a framework that can translate clinical nuance into a consistent, trusted representation across systems and use cases.” * * *
    • “Today, we rely on localized definitions of quality and accuracy shaped by providers’ current manual coding guidelines, individual workflows, and historical practices. The result is predictable: subjectivity. Agreement on accuracy across coders hovers around 50%, even among experienced and fully certified coders. In that environment, interoperability alone cannot deliver alignment.
    • “What is needed is a layer above interoperability, an objective framework for context and quality that establishes shared understanding. This framework does not eliminate variation; it normalizes it, creating a consistent and trusted output across clinical, operational, and financial use cases.
    • “Also, the framework must be uniformly administered. Acting as a compliance engine, this layer ensures that codes are not only technically correct but appropriate across use cases, clinical, financial, and analytical. When that standard is met, codes become more than billing artifacts; they become a reliable representation of patient history and a consistent entry point into the broader clinical record, regardless of where the data originated. Over time, this reduces friction across the system, including audits, denials that are ultimately reversed, and the burden of prior authorization.”

Friday update

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • Govexec reports,
    • “As the Trump administration prioritizes combating fraud in federal programs, the House this week passed almost a dozen bills, several of which are bipartisan, intended to strengthen agencies’ ability to detect and stop fraudulent payments. 
    • “The Fraud Prevention and Accountability Act (H.R. 8312) would establish an inspector general office within the Treasury Department dedicated solely to countering grift in programs that provide funding to non-federal entities.” * * *
    • “The House passed the measure in a 240-181 vote with the support of 28 Democrats.” * * * 
    • “Lawmakers also passed, without any recorded opposition, bills that would increase, from $10,000 to $20,000, the minimum monetary reward for federal employees whose disclosure of fraud, waste or mismanagement leads to cost savings (H.R. 428) and require certain government workers to receive training on preventing fraudulent and improper payments (H.R. 8428).” 
  • Per Centers for Medicare and Medicaid Services news releases,
    • “A new proposal from the Centers for Medicare & Medicaid Services (CMS) would establish a permanent framework for the Medicare Drug Price Negotiation Program (“Negotiation Program”), creating a more transparent and sustainable process for lowering drug costs for millions of Medicare beneficiaries. The proposed rule would also create greater long-term certainty for drug manufacturers that participate in negotiations. It includes policies for negotiating and renegotiating high-cost, single-source drugs beginning with initial price applicability year 2029, while continuing to support innovation and strengthen the program.
    • “This proposed rule lowers drug prices for seniors and ensures continued savings,” said CMS Administrator Dr. Mehmet Oz. “We are moving from annual updates to a permanent, predictable framework. This approach puts patients first, strengthens Medicare, and protects the innovation pipeline that delivers future cures.” * * *
    • “To view the proposed rule on the Federal Register, visit: https://www.federalregister.gov/public-inspection/current. 
    • “To view a fact sheet on the proposed rule, visit: https://www.cms.gov/files/document/mdpnp-nprm-fact-sheet.pdf. 
    • “To view Initial Price Applicability Year 2029 Key Milestones and Timeline, visit: https://www.cms.gov/files/document/mdpnp-nprm-milestones.pdf“
  • and
    • “The Centers for Medicare & Medicaid Services (CMS) is taking steps to improve healthcare quality and patient safety through enhanced oversight of Accrediting Organizations (AO). Today’s final rule, Strengthening Oversight of AO and Preventing AO Conflicts of Interest, ensures that the organizations responsible for the oversight of more than 9,000 healthcare providers and suppliers use Medicare standards, and creates greater consistency  between State Survey Agencies (SAs) and AOs in their respective survey processes. These changes will reduce provider burden, strengthen survey policies, and increase transparency.
    • “The work accrediting organizations do is vital, but it also raises an age-old question: who watches the watchmen? The answer is, we do,” said CMS Administrator Dr. Mehmet Oz. “With this new rule, CMS is advancing its commitment to upholding rigorous standards for accrediting organizations and ensuring the health and safety of American patients.”
    • “To view the final rule on the Federal Register, visit: https://www.federalregister.gov/  
    • “To view the Fact Sheet, visit: https://www.cms.gov/newsroom/fact-sheets/strengthening-cms-oversight-accrediting-organizations“
  • NCQA, writing in LinkedIn, tells us,
    • “Healthcare organizations across the country are committed to improving health equity—but many struggle with a fundamental question: how do you measure progress in a meaningful, actionable way?
    • “A new resource, Cracking the Code: A Health Equity Analytics Implementation Playbook for Healthcare Organizations, helps answer that question. The playbook offers a structured, practical approach for using advanced analytics to identify disparities, measure improvement and guide action.” * * *
    • This playbook is part of a broader effort to close gaps in care through measurement and incentives. Join us for a webinar, Beyond Measurement: Turning Health Equity Insights Into Action, hosted by The Commonwealth Fund and the California Health Care Foundation on June 30 at 3:30 pm (ET), to learn more about this work and other health equity accountability initiatives.

From the Food and Drug Administration front,

  • MedTech Dive reports,
    • “Penumbra said Thursday it received Food and Drug Administration clearance for its Thunderbolt computer assisted vacuum thrombectomy device to perform clot removal in stroke patients.
    • “The device is a first-of-its-kind treatment for acute ischemic stroke, introducing modulated aspiration technology to enable faster and more complete clot removal in neurovascular thrombectomy, Penumbra said.
    • “FDA authorization of the device is a positive for Boston Scientific, which agreed to acquire Penumbra for about $14.5 billion in January to expand in the mechanical thrombectomy and neurovascular markets.”
  • Per FDA news releases
    • The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024.
    • “Children deserve access to the best tools available to manage their health,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “Today’s clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”
  • and, for pet lovers in Texas and other States bordering on Mexico,
    • “The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old. This is the first generic animal drug authorized for use against NWS. * * *
    • “NWS flies lay eggs in open wounds or mucous membranes of mammals and the larvae hatch within hours and burrow into the animal’s flesh. Nitenpyram works quickly, killing most NWS larvae within hours of the first dose. Pet owners should administer a second dose six hours after the first. Because the effects are short-acting, Nitenpyram Tablets do not prevent NWS myiasis or protect against reinfestation.
    • “Following treatment with Nitenpyram Tablets, a veterinary professional may need to physically remove any remaining live or dead larvae. This task is best performed by someone with training in veterinary medicine to minimize the risk of infection or further tissue damage. Pet owners should consult a veterinarian about appropriate wound care and how to minimize the risk of reinfestation.
    • “Nitenpyram Tablets are available over the counter and come in two tablet sizes: 11.4 and 57 mg. Dosage is based on a dog’s or cat’s weight. Do not administer to pets less than two pounds.”

From the judicial front,

  • Benefits Pro informs us,
    • “Aetna has accused a surgeon, his wife and affiliated clinics of pumping up bills by having patients start at in-network hospitals, then sending the patients to out-of-network affiliates for many services from February 2022 through April 2026.
    • “Once the patients were at the out-of-network affiliates, the affiliates billed Aetna at high out-of-network rates, according to a complaint Aetna filed June 5 in the U.S. District Court for the District of New Jersey.
    • “The affiliates made the high rates stick by using the No Surprises Act independent dispute resolution system to approve the claims, Aetna told the court.”
  • Beckers Payer Issues summarizes “what to know about MultiPlan’s litigation saga.”
  • Healthcare Dive reports,
    • “UnitedHealth has reached a tentative settlement with the Federal Trade Commission in the agency’s lawsuit against the nation’s three largest pharmacy benefit managers for allegedly inflating the cost of insulin. 
    • “The FTC is pausing the case against UnitedHealth’s PBM Optum Rx and its group purchasing organization Emisar. The agency will consider a proposed consent agreement that would “resolve the claims against the Optum Respondents in their entirety” if approved by FTC leadership, according to an order released Friday. 
    • “The potential deal comes nearly three months after CVS Health reached a proposed settlement with the agency. Cigna’s Express Scripts settled its case with the FTC early this year.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of June 12, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity is low in most areas of the country. Emergency department visits and hospitalizations for RSV are highest among infants and children younger than 4 years old.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.
    • “Parainfluenza (PIV), a respiratory virus that can cause illnesses such as croup, is elevated nationally. Human metapneumovirus (HMPV) and rhinovirus/enterovirus (RV/EV), which often cause cold-like respiratory illness, are also elevated nationally but declining. Whooping cough is still circulating.”
  • The University of Minnesota’s CIDRAP reports,
    • “With 43 newly confirmed infections, US measles cases reached 2,073 today, the Centers for Disease Control and Prevention (CDC) said in an update, as Virginia has become the nation’s newest hot spot.
    • “All but 10 of the US infections this year are locally acquired, with the rest related to travel outside the country. The total for all of last year was 2,288 confirmed cases.
    • “The agency reported no new measles outbreaks, so that total stands at 30. The nation saw 48 outbreaks for the entire year in 2025.’ * * *
    • “The largest rise in cases has been in Virginia, with 110 listed on the CDC measles map, 20 more than last week. The Virginia Department of Health (VDH) yesterday confirmed 111 cases, 34 of which are new. Officials say 88 of the infections are linked to an outbreak in the state. Seven cases are linked to international travel, with the rest locally acquired.
    • “According to a VDH news release today, at least 88 of Virginia’s cases, or 79%, are in Buckingham County, and all have occurred in the past month.”
  • Cardiovascular Business informs us,
    • “Small changes in the heart over time may signal an increased risk of certain cancers, according to a new analysis published in the Journal of the American Heart Association.[1]
    • “The study’s authors reviewed data from the Multi-Ethnic Study of Atherosclerosis (MESA), focusing on more than 4,500 patients between the ages of 45 and 84 with available cardiac MRI results. Patients were followed for an average of 18 years.
    • “Overall, researchers found that certain cardiac MRI measurements already tracked to monitor cardiovascular health are also associated with cancer risk. For example, patients with increased heart muscle mass were more likely to go on to develop breast cancer. In addition, reduced left atrial function was linked to a greater risk of going on to develop colorectal cancer.
    • “This study suggests that structural and functional changes in the heart may occur alongside – or even before – biological processes linked to cancer development,” lead author Xinjiang Cai, MD, PhD, a UCLA Health cardiologist and member of the UCLA Health Jonsson Comprehensive Cancer Center, said in a statement. “It adds to mounting evidence that these two diseases share underlying biological pathways and are intertwined.”
    • Click here for the full study.
  • Per Health Day,
    • “Getting enough vitamin C may be linked to better brain health as we age.
    • “Researchers in Japan studied more than 2,000 adults over the age of 64, comparing vitamin C levels in their blood plasma to MRI scans of their brains.
    • “They found that participants with lower vitamin C levels tended to have lower gray matter volume. They also had weaker connectivity within the brain’s default mode network — a collection of regions involved in functions such as attention and autobiographical memory.
    • “After accounting for factors that can influence brain health, including age, physical activity and education level, those links remained.
    • “This finding generates the exciting hypothesis that a diet rich in vitamin C might play a supportive role in maintaining brain health and mitigating age-related cognitive decline in older adults,” said study coauthor Tomohiro Shintaku of the Graduate School of Medicine at Hirosaki University in Japan.”
  • and
    • “Melanoma disproportionately affects seniors and men, according to a research letter published in the June issue of the Journal of Geriatric Oncology.
    • “Megha Srivastav, from Florida Atlantic University in Boca Raton, and colleagues analyzed skin cancer incidence (2018 to 2021) and underlying causes of mortality due to skin cancer (2018 to 2023) among adults aged 65 years and older in Florida, using deidentified death certificate data from the U.S. Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research database.” * * *
    • “Taken together, our findings suggest that skin cancer in Florida is driven not only by ultraviolet exposure, but also by behavioral patterns, biological factors, and persistent gaps in prevention and early detection — particularly among older men,” senior author Lea Sacca, Ph.D., also from Florida Atlantic University, said in a statement.”
  • Genetic Engineering and BioTechnology News notes,
    • “Although gene therapy has shown promise for the treatment of Duchenne muscular dystrophy (DMD), the limitations of viral vectors have proven challenging to clinical advancement. Now, a new treatment platform delivered skeletal-muscle-targeted full-length DMD mRNA systemically in a murine model of DMD, successfully restoring the production of dystrophin, and dramatically improve muscle strength, endurance, and function in vivo.
    • “The approach uses allogenically engineered targeting extracellular vesicles (DMD t-EVs)— which offer distinct benefits over current viral-based gene therapies, including reduced side effects and the ability to transfer the entire DMD gene. The researchers engineered the EVs with special tags that directly target skeletal muscles after being injected into the bloodstream. The work also demonstrated the safety and biocompatibility of DMD t-EVs in non-human primates, supporting their translational potential.
    • “Our new platform overcomes the limitations of current viral-based gene therapies, allowing for the delivery of full-length mRNA, restoring wild-type translation of dystrophin and significantly improving muscle function,” said Betty Kim, MD, PhD, in the department of neurosurgery at UT MD Anderson. “We are highly encouraged by these results, which provide a blueprint for mRNA-loaded EVs as a next-generation therapeutic strategy.”
    • “The study, published today in Nature Biomedical Engineering, is entitled, “Skeletal-muscle-targeted non-viral delivery of full-length DMD mRNA for Duchenne muscular dystrophy.”
  • Per BioPharma Dive,
    • “Johnson & Johnson said its autoimmune drug Imaavy, touted as a top seller for the company, succeeded in a Phase 2/3 trial against a rare disease linked to anemia. The pharmaceutical giant said Thursday its drug, which is already used to treat myasthenia gravis, produced durable hemoglobin levels in people with warm autoimmune hemolytic anemia when compared to placebo after 24 weeks. The study enrolled 115 adults who received either Imaavy at two different doses or placebos. The data will be presented at the annual European Hematology Association meeting and support a drug label expansion to treat people with this disease, which has no approved treatment options, J&J said.”

From the U.S. healthcare business front,

  • Kaufman Hall tells us,
    • “Use of urgent care centers and retail health clinics varies by age, according to a report from the National Center for Health Statistics. Patients age 65 or older tended to use retail health clinics more than urgent care centers. The opposite was true for pediatric populations who visited urgent care centers almost three times as much as retail health clinics. Where patients live played only a moderate role in their preference, suggesting the importance of both options across urban and rural settings.”
  • Fierce Pharma lets us know,
    • “The share of Novo Nordisk’s Wegovy pill among total Wegovy scripts appears to have reached a plateau, hovering around one-third over the past few weeks. The latest number for the week ended on June 5 was 33%, compared with 30%, 32% and 31% in the prior weeks, according to Citi. 
    • “Meanwhile, the obesity market share split between Wegovy and Eli Lilly’s Zepbound has been relatively stable at around 40% to 42%, as the Indianapolis pharma’s oral Foundayo makes up only a small portion of the market even though its own scripts continue to build.
    • “Wegovy’s total scripts were up 9.8% on a weekly basis, reaching nearly 484,500. Within this haul, Wegovy pill contributed roughly 159,000, the oral version’s highest since its launch. The drug’s previous highest was 146,000 before dipping to 134,000 in our last update.
    • “Zepbound’s scripts also grew week over week by 9.3%, nearing 667,400 for the week. During the same period, IQVIA tracked slightly shy of 20,000 scripts from Foundayo in its ninth week on the market, compared with nearly 17,000 the prior week.”  
  • Fierce Healthcare reports,
    • “A group of partners has launched a turn-key program to help pharmacies embrace remote patient monitoring (RPM) and get reimbursed.
    • “The partnership is between telehealth infrastructure provider OpenLoop, RPM platform Tenovi and RxHealing, which provides operational support to pharmacies doing RPM. The program’s goal is to empower pharmacies, particularly independent ones in rural areas, to oversee and support chronic care patients between scheduled office visits. 
    • “There is no cost to pharmacies to stand up the program, executives said. The program will initially bill Medicare Part B, with commercial expansion planned.
    • “It’s a pretty seamless, out-of-the-box thing,” Jon Lensing, co-founder and CEO of OpenLoop, told Fierce Healthcare. “The work that [pharmacies are] getting reimbursed for now, they have historically done anyway, so for them there’s really no extra workload or lift.”

Thursday update

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

  • Smart Brief reports,
    • “AHIP26: How data sharing, simplicity can improve care
    • “Panelists at the conference discuss the challenges that data fragmentation and siloing, as well as an unwieldy system, present — and offer solutions.”

From Washington, DC,

  • Govexec reports,
    • “A bipartisan trio of House lawmakers on Thursday reintroduced legislation aimed at expanding federal workers’ access to paid leave to handle illnesses and other circumstances not included in the 2019 law granting feds paid parental leave.
    • “The Comprehensive Paid Leave for Federal Employees Act, introduced by Reps. Don Beyer, D-Va., Brian Fitzpatrick, R-Pa., and Chrissy Houlahan, D-Pa., would grant federal employees up to 12 weeks of paid family leave each year to attend to a serious health condition or to care for a spouse, child or parent. The measure would also cover absences needed to help a family member who is the survivor of domestic violence, sexual assault or stalking, as well as to attend to a family member’s deployment into active duty military service.
    • “When Congress passed the 2020 National Defense Authorization Act, the House’s version included a provision providing 12 weeks of paid parental and family leave to feds. But during negotiations with the Senate, the measure was stripped down to remove the family leave portions, and feds became eligible for paid parental leave in October 2020.”
  • The Wall Street Journal reports,
    • “If you’re a senior, the Medicare plan you choose may have a major impact on whether you can get nursing-home care when you need it—and a new federal investigation shows the largest insurers had some of the highest denial rates.
    • “Medicare insurers had widely varying rejection rates for patients seeking nursing-home stays, as well as for long-term care hospitals and inpatient rehabilitation facilities, according to two new reports from the Office of Inspector General for the Department of Health and Human Services. * * *
    • “Appealing does appear to pay off: Of the 18% of patients who did appeal, nearly all of them were able to overturn the initial denial of skilled nursing care.”
  • The American Hospital Association News relates,
    • “The Centers for Medicare & Medicaid Services June 11 released guidance detailing plans to implement new guidelines and standards for determining budget neutrality for Medicaid section 1115 demonstrations, which give states flexibility to design and test experimental approaches to Medicaid, including modifying eligibility, benefits, delivery systems and coverage, in ways not otherwise permitted under standard Medicaid authority. The guidance is intended to support implementation of a statutory requirement under the July 2025 reconciliation bill that the CMS Chief Actuary certifies that a demonstration is projected to be budget neutral, meaning it would not increase federal Medicaid spending relative to what expenditures would have been absent the demonstration. CMS said it plans to issue a rule with its proposed changes to budget neutrality.”
  • and
    • “The Centers for Medicare & Medicaid Services June 10 announced the establishment of a new Office of Health Technology and Products. CMS said the OHTP would modernize CMS healthcare technology and digital products, and transform platforms and services to support Medicare, Medicaid, the Children’s Health Insurance Program and other CMS-administered programs. The office will work closely with the CMS Chief Information Officer and be subject to CIO-led IT governance, cybersecurity, enterprise architecture, and capital planning and investment control responsibilities, among other areas. The OHTP will include new divisions, such as an Open Source Program group to develop policies and guidance around open-source frameworks, a Division of Data and Interoperability Platforms, and a Division of Policy responsible for the development of interoperability policies, regulations and sub-regulatory guidance. Additionally, the OHTP includes a Division of Core Products, responsible for the management and modernization of Medicare claims systems and provider-facing components such as the National Provider Directory. The OHTP and organizational changes became effective June 9.”
  • KFF explains how “Medicare Advantage Rebates Disadvantage Medicare’s Stand-Alone Drug Plan Market.
    • “Medicare Advantage Rebates Undermine Competition with Stand-Alone Drug Plans by Lowering Medicare Advantage Drug Plan Premiums.”
  • Beckers Hospital Review points out that “The 340B rebate fight escalates: 14 key developments.”
    • “From the first lawsuit to Lilly’s ultimatum: 18 months that reshaped the 340B program.”
  • Tammy Flanagan, writing in Govexec, discusses “Why Social Security’s funding gap matters to federal retirement.”
    • “Most federal employees under FERS rely on Social Security as part of retirement. The latest trustees report suggests the choices to preserve full benefits are getting tougher.”
  • Per a National Institutes of Health News release,
    • “National Institutes of Health (NIH) Director Jay Bhattacharya, M.D., today announced the selection of Raymond H. Jacobson, Ph.D., as the director of NIH’s Center for Scientific Review (CSR), which ensures expert and fair review of the tens of thousands of grant applications received by the agency each year. Dr. Jacobson will begin his role on June 14, 2026.
    • “Dr. Jacobson will continue strengthening NIH’s centralized peer review system so that we can continue backing the most scientifically meritorious research ideas in support of NIH’s mission,” said Dr. Bhattacharya. “His leadership will help ensure the first level of NIH review remains rigorous, fair, and transparent for all applicants.”
    • “Prior to his selection, Dr. Jacobson served as CSR’s acting director following the retirement of Dr. Bruce Reed. Dr. Jacobson helped guide NIH’s centralization of peer review, and as Acting Deputy Director of the NIH Office of Extramural Research in 2025, he advanced efforts to reduce administrative burden and address challenges faced by applicants. Additionally, he was the director of the CSR Division of Receipt and Referral beginning in December 2024, where he led efforts to simplify application receipt and referral policies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “When millions of soccer fans descend on North America [beginning today] for the 2026 FIFA World Cup, they will bring more than team jerseys and national pride.
    • They will also bring the microbes that travel with people.
    • Public health officials have spent years preparing for the tournament, which is expected to draw visitors from more than 100 countries to the United States, Canada and Mexico. Although diseases such as Ebola and hantavirus have been in the headlines, public health experts say the diseases most likely to show up in clinics, emergency departments or urgent care centers are likely to be less exotic.
    • “Instead, their top concerns include measles, dengue, respiratory viruses and sexually transmitted infections that are already circulating. These diseases are likely to spread more easily as fans crowd into airports, hotels, stadiums and festivals.
    • “Measles is what I’m most worried about,” said Krutika Kuppalli, an infectious diseases physician and associate professor at UT Southwestern Medical Center in Dallas.
    • “Texas will host 16 World Cup matches in 2026 — more than any other state — with nine matches in the Dallas-Arlington area and seven in Houston. Dallas will host more matches than any other World Cup venue, including a semifinal. The first U.S. match is Friday, in Los Angeles, when the U.S. faces off against Paraguay.”
  • and
    • “Neuroscientist Miia Kivipelto’s life’s work has been about preventing dementia. Now, at 52, she has begun thinking more about her own vulnerability.
    • “Midlife is the time,” said Kivipelto, a neuroscientist who recently joined the Yale School of Nursing as the inaugural director of its Center for Aging Well in New Haven, Connecticut. “It’s the last best chance to lower risk.”
    • “The idea that dementia prevention may hinge on what people do in their mid-30s to their 60s is rapidly reshaping the field. Scientists increasingly believe the disease is driven not only by changes in the aging brain, but also by years of metabolic stress, inflammation and vascular damage accumulating across the body. Many researchers now think the biological process that leads to dementia begins 15 to 20 years before the first memory problems emerge. By the time symptoms become noticeable, the disease likely will already be well established.
    • “Neuroscientists now see midlife as a critical window when the brain becomes especially vulnerable to aging — but also more responsive to intervention. 
    • “The implications are profound: The ordinary habits of middle age may matter far more than scientists once realized, and cognitive decline may not be inevitable.”
  • Per a National Institutes of Health news release,
    • “A research consortium funded by the National Institutes of Health (NIH) has established a new framework to identify and catalog senescent cells – cells that stop dividing but remain active in the body. Because senescent cells accumulate with age and are thought to contribute to many age-related conditions, researchers are working to better understand the roles they play in health and disease. In a compendium of papers published in the June 11 issue of Cell, the consortium presents the first comprehensive atlas of senescent cells across the human body, a foundational step toward developing new therapies for age-related diseases.
    • ‘In healthy tissues, senescent cells support wound healing and serve as a defense mechanism by preventing the growth of tumors. They are normally cleared by the immune system, but as immune function declines with age, senescent cells accumulate in the body instead of being eliminated. Over time, these cells then release harmful signals that contribute to chronic disease and other age-related conditions. While removing these cells has been shown to diminish the impact of aging, their rarity and diversity have made them difficult to study.
    • “To address this challenge, the NIH Common Fund launched the Cellular Senescence Network (SenNet) program in 2021 to identify and characterize senescent cells across the human body.
    • “Through the new papers, researchers in the consortium are introducing the concept of “senotypes,” a new classification system that groups senescent cells based on where they are found in the body and the conditions surrounding them.
    • “By mapping where different senotypes are found and what makes them unique, we aim to build a more complete picture of senescent cells across the body,” said Nicole Kleinstreuer, Ph.D., NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives (DPCPSI), who leads the NIH Common Fund. “This knowledge could help researchers move toward more targeted therapies that focus on harmful cells while preserving beneficial ones.”
  • MedPage Today tells us,
    • “Research has suggested that consumption of sugar-sweetened beverages is linked to increased risks of certain cancers.
    • “A pooled analysis of 11 studies showed that sugar-sweetened beverage intake was not associated with overall liver cancer risk but was tied to increased risks of hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
    • ‘Of note, there was no association between consumption of artificially sweetened beverages and liver cancer overall, or by subtype.
  • Health Day informs us,
    • “Sleep apnea might affect women worse than men.
    • “Women had similar outward symptoms of sleep apnea.
    • “However, they reported higher levels of side effects.”
  • STAT News lets us know,
    • “A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, including higher response rates in patients treated at an earlier stage of their disease.
    • “The updated early-stage study results reported Thursday for the Enliven drug, ELVN-001, compare favorably to a current blockbuster medicine sold by Novartis and an upstart experimental drug recently bought by Merck.” * * *
    • “Enliven has met with the Food and Drug Administration and received clearance to start a Phase 3 study later this year that will enroll patients with CML previously treated with one or more drugs. The study will compare ELVN-001 against a physician’s choice of currently approved CML drugs, excluding Scemblix.
    • “The company believes the addressable commercial market for ELVN-001 as a “second-line plus” treatment option for CML is worth $5 billion.”
  • Biopharma Dive adds,
    • “Takeda’s experimental autoimmune drug zasocitinib bested Bristol Myers Squibb’s marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday.  
    • “Takeda didn’t provide detailed data but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. It’s the second time Takeda’s drug has beaten an approved therapy, following positive results in a trial testing it against Amgen’s Otezla. 
    • “Zasocitinib is a newer kind of “TYK2 inhibitor,” a class of oral autoimmune medicines that have attracted significant industry investment in recent years. It’s become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.”
  • and
    • “An RNA drug Novartis acquired as part of its $12 billion bet on Avidity Biosciences succeeded in a trial of patients with a rare neuromuscular disease, Novartis said Thursday.
    • “Called delpacibart braxlosiran, the experimental drug met its primary biomarker endpoint in a Phase 1/2 study evaluating the treatment in a muscle-wasting disease known as facioscapulohumeral muscular dystrophy, or FSHD. The drug, a so-called “antisense oligonucleotide conjugate” or AOC, is designed to restore muscle function and help slow progression of the disease.
    • “Del-brax targets a gene called DUX4, which is expressed incorrectly in patients with FSHD.”

From the U.S. healthcare business and artificial intelligence front,

  • Modern Healthcare reports,
    • “Group healthcare costs are expected to rise 9% in 2027 as Americans use more services. 
    • “The growing use of expensive drugs, the proliferation of mental health issues and reimbursement pressures will drive healthcare cost inflation, according to a Thursday report from consultancy PwC.”
    • “Researchers spoke with actuaries at 27 health insurers that cover 103 million employer-sponsored members and 8 million Affordable Care Act enrollees to forecast healthcare inflation. 
    • “PwC projected an 8.5% increase for the individual market. In addition to the 2027 projections, the consultancy retroactively adjusted last year’s group cost growth estimate to 9% from 8.5% and the individual market projection to 8.5% from 7.5%.”
  • and
    • “U.S. companies plan to charge more for employee health plans next year, as soaring drug prices drive up insurance costs.
    • “Two-thirds of large companies expect to raise monthly premiums for employee health coverage through paycheck deductions in 2027, according to a survey of businesses with at least 500 employees by benefits consultancy Mercer. And about half (48%) of employers say they will make other changes, such as raising deductibles and copays, that will increase how much workers pay out of pocket for care.”
    • “It isn’t just employees who will be paying more. Health insurers are raising costs for employers, too, with the cost of group plans set to increase by more than 6% for the fourth year in a row, said Beth Umland, Mercer’s director of research. Annual increases previously hovered around 3% for more than a decade.
    • “Although employers initially tried to absorb those higher costs, they are beginning to pass them onto workers, Umland said. This year, employers expect to pay more than $18,500 per employee for health care benefits, a 6.7% increase from 2025 and the biggest jump in 15 years.”
  • MedCity News adds
    • “If you want to know where healthcare finance is headed, ask the people who lend hospitals money. 
    • “During a Tuesday panel at the HFMA Annual Conference in National Harbor, Maryland, two veteran healthcare credit analysts said they think the window for deliberate strategic action is closing faster than most health system leaders realize.
    • “We love incremental change in healthcare — it’s not going to work anymore,” said Kevin Holloran, senior director of nonprofit healthcare group at Fitch Ratings. “We’ve got to have some really bold thoughts and really bold moves if we’re going to be ready for 2030 and then beyond.”
    • “His urgency stems from a stark demographic reality. In 2030, the last of the Baby Boomer generation will officially reach age 65 and become Medicare-eligible. This is the same year that the most significant cuts from the federal budget reconciliation legislation will begin to bite.” * * *
    • “2030 scares me to death,” Holloran declared. “Right when you get fewer people in the workforce, you’re going to see your payer mix decline. You’re going to go from commercial to Medicare — and you’re not going to have enough people, as they’ve left the workforce.”
  • Healthcare Dive relates,
    • “Health plans are projecting commercial healthcare costs will rise 9% next year, driven in part by increased adoption of artificial intelligence billing tools by providers, according to a report released Thursday by professional services firm PwC.
    • “Nearly 70% of surveyed plans ranked providers’ use of AI documentation and coding products as a top three inflator next year, while about 20% called AI the number one inflationary trend. 
    • “Still, AI isn’t a major driver of growing healthcare costs compared with labor and supply cost inflation or increased healthcare utilization, said Glenn Hunzinger, U.S. health industries leader at PwC. “The ability to use technology and AI to more appropriately code or code things that they were never able to, that’s the trend we’re seeing,” he said. “It does have an impact on that 9%, albeit it’s not the biggest piece.”
  • Fierce Healthcare adds,
    • “Since launching eight years ago with an ambient medical transcription tool, Abridge has set is sights more broadly on building out a full-scale AI clinical assistant. The company is steadily developing tech and features to assist with billing, prior authorization and clinical decision making.
    • “Today, the company announced a major platform expansion to integrate payer and life sciences workflows. Described as an “AI-native clinician intelligence platform,” Abridge says it now connects care delivery, payment and evidence-based treatment.
    • “Abridge CEO and co-founder Shiv Rao, M.D., announced Thursday at an event in New York City that pharma giant Eli Lilly and Company made a strategic investment in the company to “support evidence-based care and research.” The financial details of the investment were not disclosed.”
  • Coviti points out,
    • “Improper use of modifier codes in radiology can lead to excessive billing, often misrepresenting radiology services and diminishing trust between providers and health plans. As new requirements and measures emerge, special investigative units (SIUs) should remain vigilant with claims analyses and proper documentation to reduce overpayments.
    • “This month’s edition of FWA Insights dives into outlier billing for modifier codes and excessive services in radiology, revealing the ramifications of medical coding discrepancies and providing practical steps to prevent fraud, waste, and abuse (FWA).”
  • Per an Institute of Clincal and Economic Research (ICER) news release,
    • “The Institute for Clinical and Economic Review (ICER) today released its revised Evidence Report assessing the comparative clinical effectiveness and value of vaccines for protection against Covid-19, including: Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Sanofi).
    • “Covid-19 infections continue to occur year-round, sometimes leading to serious illness or death,” said ICER’s Chief Medical Officer, David Rind, MD, MSc. “For any preventive care, the goal is always to understand whether the potential benefits outweigh the potential harms. ICER evaluated the evidence for Covid-19 vaccines in 12 US sub-populations. Current evidence suggests that the greatest net benefit of Covid-19 vaccination is in pregnant women; infants aged 6 months to one year; and adults over the age of 65, with the net benefit increasing further with increasing age. Declining rates of serious Covid-19 year over year necessarily create some uncertainties. We hope this report will be a useful resource to policymakers and public health officials as they consider vaccination recommendations for Covid-19 for the 2026-2027 season.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on June 25, 2026. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.
    • “Register here to watch the live webcast of the virtual meeting.“
  • Fierce Healthcare tells us,
    • “Humana announced this week that it intends to divest its minority stake in Gentiva, the largest provider of end-of-life care in the country.
    • “The company said Wednesday that it has entered into a definitive agreement to sell off “all or substantially all” of its stake in Gentiva to a “consortium of investors.” The agreement puts the value of Humana’s stake in Gentiva at about $900 million, according to an announcement.
    • “Other financial terms related to the deal were not disclosed, and it’s expected to close in the third quarter of 2026, pending regulatory approval. Details on which investors are involved were also not made public.
    • “Humana said in the announcement that it plans to use the funds from the sale for “general corporate purposes,” and said it does not expect that the deal will have a material impact on its earnings for the year.”
  • BioPharma Dive informs us,
    • “Parabilis Medicines, a high-profile startup making medicines for “undruggable” targets, raised $670 million in an initial public offering on Wednesday, a record haul for a venture-backed biotechnology company.
    • “Parabilis boosted the size of its offering and ultimately sold 33.5 million shares at $20 apiece, eclipsing the amounts secured by Moderna in 2018 and Kailera Therapeutics earlier this year. It added another $75 million through a discounted private stock sale to new research partner Regeneron Pharmaceuticals.
    • ‘The IPO extends a streak this year for large new biotech stock offerings. So far in 2026 a dozen drugmakers have gone public and raised a median of about $300 million each, more than doubling the median total biotech startups secured in IPOs last year, according to BioPharma Dive data.” 
  • Per MedTech Dive,
    • “Danaher has completed its $9.9 billion takeover of Masimo, establishing itself as a competitor to Medtronic in the pulse oximetry market. 
    • “The completion of the purchase, which Danaher reported Wednesday, positions the company to start integrating Masimo in pursuit of more than $125 million of annual cost synergies and more than $50 million of annual sales synergies by the fifth full year after the deal closure.
    • “Masimo will slot into a diagnostics portfolio that features Radiometer, a Danaher business that specializes in blood gas analysis and other testing in acute care settings.”
  • and
    • “Insulet is developing an automated insulin delivery system that will be “completely different” than its competitors, Chief Medical Officer Trang Ly said in an interview after the American Diabetes Association’s Scientific Sessions. 
    • “The system, which Insulet calls “fully closed loop,” is for people with Type 2 diabetes and does not require carb-counting or insulin bolusing ahead of meals. Physicians also don’t need to program the starting settings, and dose titration is automated. 
    • “With our system there’s no bolusing at all. There’s actually no bolus button. … It’s completely different to what Medtronic and Tandem and everyone else is working on,” Ly said. “There are no settings for anyone to enter.” 
    • “Insulet shared results of its Evolution 3 study of the planned system at the conference on Saturday. The study built on previous results the company shared at another diabetes conference in March.”

Tuesday report

David Ermer–CDC, Congress, FDA, Federal employment benefits, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • The Wall Street Journal reports,
    • The House [of Representatives] passed a Republican-led $70 billion immigration-enforcement bill Tuesday, ending a monthslong stalemate over the slice of federal spending, and funding the contentious operations through the rest of President Trump’s second term.
    • The bill, which passed 214-212, comes after the Senate narrowly cleared funding for the agencies last week, using a special budget process that allowed Republicans to bypass the 60-vote threshold for most bills. Congress had approved funding for most of the Department of Homeland Security earlier this year, but Democratic opposition had held up money for Immigration and Customs Enforcement and Border Patrol. Trump is expected to sign the measure into law.
  • Healthcare Dive relates,
    • “A key House panel voted unanimously Tuesday to end a pilot program testing prior authorizations in fee-for-service Medicare.
    • “The House Appropriations Committee approved legislative language that would bar the Centers for Medicare and Medicaid Services from spending money to implement the Wasteful and Inappropriate Service Reduction Model, or WISeR, which the agency launched in six states this January. This provision was amended to a bill to fund the Health and Human Services Department in fiscal 2027, which the panel is still considering.”
    • Providers have blasted WISeR, a six-year demonstration that is partly reliant on artificial intelligence and is being managed by technology companies. 
    • The HHS appropriations bill must clear more hurdles, including advancing out of committee, passing the House and being reconciled with the Senate’s pending version of the spending package, before the WISeR provisions would become law.
  • Govexec tells us,
    • “Rep. Raja Krishnamoorthi, D-Ill., on Tuesday said the Trump administration’s recently unveiled plan to make federal employees sign a non-disclosure agreement “threatens” the federal workforce’s constitutional rights and creates a chilling effect on would-be whistleblowers and demanded information into how it was developed.
    • “Last month, the Office of Personnel Management formally proposed requiring all federal employees to sign NDAs barring them from divulging “confidential” information in most cases, prompting swift outcry from civil service groups and employment lawyers. A draft copy of the document bars signatories from disclosing information related to internal agency operations, personnel and procurement matters and “any sensitive, pre-decisional or deliberative material.”
    • “In a letter to OPM Director Scott Kupor, the Illinois Democrat criticized the proposal as “over-broad” and likely to make it more difficult for whistleblowers to divulge allegations of waste, fraud and abuse.” * * *
    • “The Democrat demanded information on OPM’s legal analysis of whether the proposed NDA comports with the First Amendment and the Whistleblower Protection Act, a definition of “confidential” for the purposes of the document, as well as any potential consequences federal employees who refuse to sign the agreement would face, and whether it would apply equally to both career employees and political appointees.”
  • Federal News Network discusses “OPM[‘s] details [about] changes for federal employees in Schedule Policy/Career.”
    • “As agencies gear up for implementation, OPM detailed what Schedule Policy/Career will mean for recruitment, adverse actions and other personnel policies.” * * *
    • “Implementation instructions for agencies on Schedule Policy/Career are now available in guidance that the Office of Personnel Management published Monday.” 
  • The Government Accountability Office issued a report titled “Federal Workforce: Executive Actions Reshaped Probationary Employment Rules and Reduced Staff Levels at Selected Agencies.”
    • “Since January 2025, in response to presidential directives and accompanying Office of Personnel Management (OPM) guidance, many federal agencies have taken steps to reduce their probationary and trial employee staffing levels. These are employees who have not yet completed the service requirements necessary to finalize their appointments, either after being newly hired or after being appointed as a supervisor or manager. Probationary periods are generally 1 or 2 years during which probationary and trial employees have limited job protections.” * * *
    • “GAO’s analysis of OPM’s Federal Workforce Data (FWD) found that, in 2025, probationary employees separated from 11 selected agencies at a slightly higher rate (19 percent) compared to all employees who separated from these agencies (15 percent). Over two-thirds of these separating probationary employees did so voluntarily as did all employees who separated from these agencies.
    • “Across most selected agencies in 2025, a greater proportion of probationary employees separated compared to all employees who separated. At the Department of Energy, for instance, about 34 percent of probationary employees separated, compared with 19 percent of all employees. The Department of Defense recorded the largest number of probationary separations—about 20,000 employees—but separation rates for probationary employees and the overall Defense workforce were nearly identical, at about 14 percent.”
  • The Wall Street Journal lets us know,
    • “Social Security is expected to deplete the fund that helps pay out retirement benefits by late 2032, the program’s trustees said Tuesday.
    • “That is earlier than their projection last year of 2033, partly because the fund expects to collect less revenue after President Trump’s new tax law. Passed last summer, the law gave senior citizens an extra deduction that reduced taxes on benefits for many Social Security recipients. 
    • “Revenues are also shrinking because declining fertility rates and immigration are reducing tax revenue by cutting the number of workers paying into the system, according to the trustees.
    • “The trustees reduced their long-term expectations for fertility rates on Tuesday, indicating they will remain lower for longer than previously projected.” * * *
    • “Unless Congress shores up the retirement program, the depletion of reserves would trigger a 22% reduction in benefits in late 2032. Because incoming payroll tax revenue doesn’t fully cover promised benefits, the program is forced to make up the difference by pulling money from its two Social Security trust funds—one for disability benefits and the other for the larger program for retirees.
    • Congress could temporarily use money from the disability trust fund to prop up the retirement fund. But that is a short-term solution because on a combined basis, the two funds are projected to become insolvent in the third quarter of 2034, according to the trustees.” * * *
    • “To shore up the system, lawmakers could borrow more, raise taxes, reduce benefits or reach an agreement that combines those measures.”
  • Fierce Healthcare points out,
    • “More than 500 hospitals falling short on price transparency requirements have received warnings from the federal government since April, with more “likely” to receive similar notices soon, the AP reported Tuesday morning. 
    • “The outlet’s report cited an unnamed “senior administration official” who shared a list of 519 nationwide hospitals that recently received either a warning notice or a Corrective Action Plan (CAP) request. 
    • “The former is an initial 90-day warning from the Centers for Medicare and Medicaid Services with instructions to correct any deficiencies, while the latter is a subsequent 45-day deadline for a hospital to submit a more concrete plan to address its compliance deficiencies. 
    • “For hospitals that do not come into compliance following these, CMS issues a civil monetary penalty that scales with bed count. These can run as high as $5,500 per day, or over $2 million per year. Twenty-eight hospitals have been issued civil monetary penalty notices to date, according to CMS.
    • “Among the list of warned hospitals obtained by the AP, Texas led other states with 42 notified facilities, followed by 38 in California, 34 in Indiana and 27 in Louisiana.” 
  • The American Hospital Association News notes,
    • “The Department of Health and Human Services June 8 released a request for information on research, policy and strategies to improve addiction and mental illness prevention, treatment and recovery. HHS said it it seeks to identify successful initiatives, recommend novel policy ideas and address research gaps. Comments are due to HHS by July 5.”

From the Food and Drug Administration front,

  • Per a FDA news release,
    • “Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency’s efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
    • ““As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
    • “FDA finalized this action within seven months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.
    • “Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.”
  • MedTech Dive adds,
    • “Medtronic has received Food and Drug Administration clearance for an updated version of its Nellcor pulse oximetry system.
    • “The 510(k) clearance, which Medtronic disclosed Monday, covers a device with a new processor designed to support more consistent and reliable results across diverse skin tones. 
    • “Concerns about the accuracy of pulse oximeters in people with darker skin pigmentation led the FDA to publish draft guidance on the devices last year.”

From the public health and medical / Rx research front,

  • The Wall Street Journal reports,
    • “[M]illions of Americans [suffer] with cardiovascular-kidney-metabolic syndrome, a disorder defined in 2023 by the American Heart Association. It describes a cluster of conditions—heart disease, diabetes, kidney disease—that have common risk factors and fuel one another. Long treated as isolated or individual diseases, the conditions are interrelated, usually tied to excess abdominal fat, and a major driver of heart disease, according to the AHA.
    • “On Tuesday, the AHA and three other medical societies published the first guidelines to help clinicians prevent and manage CKM, as it is called, urging them to focus on their patients’ overall metabolic health. The goal is to prevent or slow the progression of conditions that may ultimately lead to heart attacks and strokes, which are becoming more common in younger adults.
    • “The new guidelines call for doctors—from primary care to cardiology—to screen patients for metabolic risk factors and kidney function routinely. Risk from excess fat should be measured both by body-mass index (BMI) and waist circumference, according to the new guidelines, which were developed by the AHA and the American College of Cardiology with the American Diabetes Association and American Society of Nephrology.
    • “In the 1970s, smoking, high blood pressure and cholesterol were the classic risk factors for heart disease, said Dr. Chiadi Ndumele, chair of the committee that wrote the new guideline and a preventive cardiologist at Johns Hopkins University School of Medicine. Today, excess abdominal fat is a major risk factor because it can trigger chronic inflammation that damages arteries, cardiac tissue and kidneys, he said.”
  • The New York Times relates,
    • “A government alcohol study published on Tuesday concluded that the health risks of alcohol start at a single drink a day. The report was caught up in controversy after drawing the ire of the alcohol industry.
    • “At one drink a day, the researchers found, there was an increased risk of premature death from an illness or injury directly attributable to alcohol, though it was small — one in 1,000 people. But the risk of premature death jumped to one in 25 for those who had two drinks a day, a level long considered safe for men, according to the study, which was published in the Journal of Studies on Alcohol and Drugs.
    • “The Alcohol Intake and Health Study was one of two reports commissioned during the Biden administration to inform an update to the U.S. dietary guidelines.
    • “The second report, from a panel appointed by the National Academies of Sciences, Engineering and Medicine, or NASEM, came to very different conclusions. It suggested that moderate drinking (up to two drinks a day for men and one for women) was healthier than not drinking at all, although it noted that moderate drinking was also linked to a higher breast cancer risk. Some of the panelists behind that report had financial ties to the alcohol industry.”
    • * * * “One reason the studies reached such different conclusions is that while the new study examined deaths from causes directly attributable to alcohol, the NASEM report commissioned by Congress looked at overall death rates of moderate drinkers, including deaths not causally related to alcohol.
    • “Critics of the NASEM report say that people who drink in moderation often have other healthy lifestyle habits that contribute to their longevity. The moderate drinking group also included many people who consumed less than two drinks a day. Both of these factors could make the health effects of moderate drinking look less significant than they might be.
    • “Dr. Ned Calonge, an epidemiologist at the University of Colorado Anschutz Medical Campus who led the NASEM study, said he stood by its conclusions.
    • “Alcohol research is complex and I am not surprised by different methods producing different results,” Dr. Calonge said, adding that modeling studies like the Alcohol Intake and Health Study, which use data to estimate the lifetime risk of diseases and deaths caused by alcohol, also come with potential biases.
    • “At the same time, he added “I don’t believe anyone should start drinking for health reasons.”
  • and
    • “The U.S. Department of Agriculture announced three new cases of New World screwworm, including the first cases in dogs and goats, on Monday, bringing the nation’s total case count to five. It also pledged to ramp up and expedite mitigation efforts for screwworm, a parasitic fly that the nation declared eradicated in the 1960s.
    • “At a news briefing on Monday, federal and Texas state officials said that they were using technology driven by artificial intelligence to monitor screwworm populations, training ranchers to recognize infections in their livestock and expanding the number of facilities that produce and disperse sterile flies, which are the primary tool for managing screwworm.
    • “Officials are also considering whether to grant an emergency authorization of a new, genetically engineered strain of flies that could make sterile fly production faster and more efficient.
    • “We prevented and eradicated this pest before,” Gov. Greg Abbott, Republican of Texas, said during the briefing. “We can do it again.” * * *
    • “The New World screwworm is a blowfly that feeds on living flesh. Adult females lay their eggs in open wounds or orifices of warm-blooded animals. When the eggs hatch, the larvae burrow into the wound, consuming the animal’s tissue. Untreated, screwworm infections can kill animals within a week.
    • “In humans, screwworm infections are rare. Last year, American health officials confirmed a travel-related case in a Maryland resident who had recently traveled to El Salvador, but no domestically acquired human cases have been reported yet.”
  • Health Day adds,
    •  There’s a biological reason why booze makes a person crave bar snacks like chips, nuts, fries and pizza, a new study argues.
    • Alcohol appears to trigger a hormone associated with cravings for savory flavors, researchers reported recently in the journal Obesity Reviews.
    • This hormone, FGF21, is linked to protein appetite and, when activated, can shift cravings toward salty, umami-flavored foods, researchers found.
    • “Many people will recognize the experience of having a few drinks and suddenly craving something salty, like chips, French fries, pizza or other savory foods,” said lead researcher Amanda Grech, a research associate at the University of Sydney’s Charles Perkins Center.
    • “Now we have a better understanding of the hormonal dynamic at play, which may be driving overconsumption of ultra-processed foods,” Grech said in a news release.
  • Cigna Healthcare, writing in LinkedIn, discusses “Men’s Mental Health Awareness Month [meaning this month]: Making Room for What Men Carry—At Work and Beyond.”
    • “Men’s Mental Health Awareness Month is an invitation to redefine strength as something sustainable: self-awareness, early help-seeking, and staying connected under pressure. In any workplace, the most meaningful shift isn’t a grand statement—it’s a steady message, reinforced over time, that dignity comes first and support is not something you have to earn. When men are met with respect, privacy, and real permission to be human, it becomes easier to speak earlier, connect more honestly, and get care before strain becomes a crisis.”
  • MedPage Today tells us,
    • “While the American Academy of Pediatrics now recommends introducing certain allergenic foods by ages 4-6 months for all children, guidelines from the 1990s and 2000s had recommended delaying introduction until 1-3 years.
    • “As the proportion of infants introduced to egg by 6 months of age increased from 2007-2011 to 2018-2019, egg allergy prevalence adjusted for changes in known allergy risk factors fell from 9.2% to 7.6%.
    • “Infants with early-onset eczema saw the biggest impact, with egg allergy prevalence decreasing from 34.6% to 21.9%.”
  • and
    • “Respiratory tract infections (RTIs) continue to be a substantial cause of mortality in children under 5 and contribute to morbidity, hospitalizations, and healthcare costs.
    • “Nearly one in four of the current study’s hospitalized pediatric patients with acute RTIs developed severe disease.
    • “Increased risk was highest in kids with two or more underlying conditions or who were transferred from a referring hospital.”
  • The National Institutes of Health’s Reseach in Context considers “Understanding the exposome.”
    • “Tracking how the environment affects health
    • “The world around us influences our health in countless ways. This special Research in Context feature explores how scientists are using new technologies and approaches to measure the exposome—the total set of environmental exposures people encounter throughout life and their biological response to them.
  • Genetic Engineering and Biotechnology News points out,
    • “When Jingkun Zeng, PhD, joined the lab of Nobel laureate, Jennifer Doudna, PhD, as a postdoctoral researcher in 2024, he was not interested in applying CRISPR for gene editing. 
    • “The molecular scissors had demonstrated extraordinary clinical promise in correcting single-point mutations, most strikingly in Baby KJ’s case, where a rare metabolic disorder once presented a 50% mortality rate in infancy. 
    • “Yet, Zeng had his ambitious sights on stopping cancer progression, where the biology “became messy.” Cancer can be driven by hundreds of thousands of mutations, making it nearly impossible to correct each mutation one-by-one to restore healthy function. 
    • “Zeng, who completed his PhD training in cancer evolution at The Francis Crick Institute, aimed to develop new CRISPR-based technology that could therapeutically access the undruggable tumor suppressor protein, p53. Mutations in this “guardian of the genome” are found in nearly half of all cancers, and up to 70–90% of cases of the most deadly tumors, including ovarian, pancreatic, and non-small cell lung cancer. 
    • “In a new study published in Nature titled, “Targeting Cancer-Specific Mutations with RNA-Triggered Chromatin Shredding,” Zeng and colleagues from Innovative Genomics Institute (IGI), University of California (UC) Berkeley, UC San Francisco (UCSF), and Gladstone Institutes, have now engineered a CRISPR system to selectively trigger cancer cell death by chromatin shredding.  
    • “The approach recognizes cancer cells using the RNA-guided nuclease, CRISPR-Cas12a2, to recognizemutant p53 mRNA transcripts. Therapeutic effectiveness was demonstrated in mouse models of lung and liver tumors.” 
  • Per Fierce Pharma,
    • “A combination of Merck’s islatravir and Gilead’s lenacapavir has succeeded in two phase 3 trials and is in line to become the first long-acting oral HIV treatment that can be taken weekly.
    • “Both trials of the combination regimen—which includes a 2 mg dose of islatravir and a 300 mg dose of lenacapavir—included people with HIV who are virologically suppressed and both achieved their primary efficacy endpoint. 
    • “In the Islend-1 study, the combo showed its non-inferiority in those who had switched off Gilead’s once-daily pill Biktarvy. In Islend-2, the combo measured up in those who had switched off standard-of-care antiretroviral regimens. No new safety concerns were identified in either study.”
  • and
    • “Following another phase 3 failure for Gilead Sciences’ Trodelvy, the race to bring a TROP2 antibody-drug conjugate (ADC) to patients with first-line non-small cell lung cancer (NSCLC) has narrowed. 
    • “Monday, Merck & Co. and Gilead announced that they are pulling the plug on the phase 3 Evoke-03 trial, also known as Keynote-D46, following the recommendation of an external data monitoring committee. 
    • “The study was evaluating Trodelvy, combined with Keytruda, as a first-line treatment in patients with PD-L1-high NSCLC versus Keytruda alone.” * * *
    • “Without a win in first-line NSCLC, Trodelvy’s commercial future will mainly depend on its triple-negative breast cancer uses, which won’t be able to justify the $21 billion price tag that Gilead paid for the med’s developer, Immunomedics. Gilead already took major write-offs tied to Trodelvy’s second-line NSCLC failure and a market withdrawal in bladder cancer in 2024.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Health insurance executives convene this week in Las Vegas at a time when the industry is facing significant pressure on cost, access and policy changes.
    • “AHIP’s annual conference kicks off Tuesday morning, with two days of sessions and discussions that center on the major challenges facing insurers today, from new technologies to consumer engagement to rising medical costs.
    • “Fierce Healthcare will be on-site this week to provide key insights from the show floor, but before the conference opens, [the article offers] a look at some of the biggest themes to watch on the agenda.”
  • Beckers Hospital Review relates,
    • “Springfield, Mass.-based Baystate Health is planning to acquire a financially challenged hospital in the city from Hartford, Conn.-based Trinity Health of New England for $293 million through a member substitution valued at $293 million. 
    • “Baystate signed a definitive agreement in April to acquire Mercy Medical Center, a 182-bed acute care hospital, as well as Mercy’s joint ventures and affiliated medical groups from Trinity Health of New England, which is part of Livonia, Mich.-based Trinity Health. 
    • “As part of the regulatory approval process, Baystate is required to get a determination of need from the Massachusetts Department of Public Health. According to a filing with the department, MMC has experienced “significant and continued operating losses in recent years.”
  • and
    • “The American Medical Association’s House of Delegates voted to formally oppose use of the term “provider” when referring to physicians, adopting the new policy at its Annual Meeting in Chicago this week.
    • “The vote builds on existing AMA policy that already calls on healthcare entities to specify the type of clinician — using their recognized title and credentials — when using the term “provider” in contracts, advertising and other communications. It also directed AMA to prohibit use of the term in its own publications.
    • “The new policy goes further, directing the AMA to actively oppose the term when it encompasses physicians and to implement the existing policy’s external advocacy provisions, which had not yet been fully advanced.
    • “The AMA argues that the term “provider” undermines patient education, transparency and physician professionalism, and poses risks to patient safety by obscuring the distinctions among clinician types and their training, according to a June 9 news release.”
  • Radiology Business adds,
    • “The radiologist shortage is real, but it may be smaller and more local than previous reports might indicate, according to new research. 
    • “About 47% of “open” radiologist jobs are reposts of the same role. However, the “real shortage” appears to be “concentrated and stubborn,” according to an analysis shared by RadBoard, an artificial intelligence-powered platform for researching jobs in the specialty. 
    • ‘Approximately 1,470 of active radiologist openings have been sitting unfilled for over two months or more. 
    • “Most aren’t underpaid—they’re geographically inconvenient,” writes report author Kirill Lopatin, founder and CEO of xAID, which offers AI solutions to radiology groups.” 
  • The Wall Street Journal tells us,
    • GSK GSK [symbol]  agreed to buy U.S. cancer-drug developer Nuvalent NUVL for $10.6 billion, the British pharmaceutical company’s latest move to bolster its oncology business.
    • The acquisition is set to give GSK two drug candidates for lung cancer that are currently under review by the U.S. Food and Drug Administration as well as a third, earlier-stage medicine, the London-based company said Tuesday.
    • The deal comes as GSK works to rebuild its position in the market for cancer treatments, one of the most lucrative areas of the pharmaceuticals industry. GSK exited oncology in 2015 as part of a broader asset-swap deal with Switzerland’s Novartis. The company has since returned to the market with the acquisitions of Tesaro, Sierra Oncology and IDRx as well as licensing deals.
    • “Our strategy has been a brick-by-brick building approach,” GSK Chief Executive Luke Miels said, adding that the company would continue to look for further opportunities.
  • STAT News informs us,
    • “The number of prescription drug shortages in the U.S. fell by 23% last year, marking the second consecutive year of declines and the lowest level since 2017, according to a new analysis that otherwise found troubling signs about medicines that are in short supply.
    • “For instance, the average drug shortage lasted 5.3 years, exceeding the 4.3 years seen in 2024 and greatly outpacing the average two-year shortage experienced in 2019. Moreover, nearly two-thirds of out-of-stock medicines were in short supply for more than three years, and 39% were unavailable for more than five years.
    • “Meanwhile, the 75 drugs that were in short supply last year spanned 130 therapeutic categories, indicating that shortages affected a wide range of diseases and patient populations, according to the analysis by U.S. Pharmacopeia, an independent organization that develops standards for medicines.”
    • “At first glance, the numbers do appear conflicting and suggest some progress, but the overall trends are troubling, said Matthew Christian, director of supply chain insights at the organization. “The problems we have are systemic. They are not resolved and they are not new. They’re old and not going away.”
  • A commentator in Healthcare IT Today explains “The Emerging Role of AI Platforms in Healthcare Delivery: What Healthcare Leaders Need to Know.”
    • “With the launch of ChatGPT Health and Claude for Healthcare, AI has moved from the margins of healthcare IT to its center. It will define how patients engage with care and how clinicians deliver it.
    • “Participation is inevitable. Leadership is not. Organizations that act now will shape the future of care. Those that wait will inherit it.”
  • Fierce Healthcare adds,
    • “More than one-third of clinicians say artificial intelligence use is allowing them to see more patients, with a median of five additional patients per week, a new report from Philips found.
    • “The Future Health Index 2026 (PDF) drew insights from more than 2,000 healthcare professionals and more than 20,000 patients across 10 countries. 
    • “Nearly three-quarters (74%) of clinicians say their use of AI-enabled tools provided by their organization has increased over the past year. Among surveyed clinicians, 52% are using AI to transcribe clinical notes and close to half (46%) are using generative AI as a professional “buddy” to discuss work-related ideas. AI use is also growing for clinical decision support as 45% use AI tools to suggest diagnoses based on patient symptoms and 44% use AI-enabled tools to flag potential dangerous drug combinations.”
  • Per MedTech Dive,
    • “Research shared by Dexcom at the American Diabetes Association’s Scientific Sessions last weekend showed that people who have Type 2 diabetes but don’t take insulin could still benefit from wearing a glucose sensor.
    • “Dexcom telegraphed the study results ahead of the conference in a May earnings call, with CEO Jake Leach saying he expected the results could support a Medicare coverage decision “between now and the end of this year.”
    • “Thomas Martens, a medical director at the International Diabetes Center in Minneapolis and co-author of the study, said the research was intended to answer the question of whether continuous glucose monitors, or CGMs, can improve diabetes management for people who don’t take insulin. The study was funded by Dexcom.” * * *
    • “People who used the CGM had an average hemoglobin A1C reduction of 1.6% from the baseline level of 8.8%. The result was a 0.9% greater A1C reduction than the control group, which Martens said was “striking.” 
    • “People who used the CGM also had better time in range, a measure of how much time during the day a person stays within a target blood glucose range. The Dexcom G7 users had a 62% time in range compared with 41% in the control group.”

Monday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call takes a look at what’s ahead of Congress this week,
  • and also lets us know,
    • “President Donald Trump on Monday sent to the Senate the nomination of acting Attorney General Todd Blanche to fill the role permanently, teeing up what could be a bruising confirmation process for a Trump ally who has drawn bipartisan criticism for recent Justice Department moves.”
  • Per a HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Education today hosted eight of the nation’s leading accreditors, assessors, and medical organizations to announce a historic development to increase nutrition requirements at every level of U.S. medical education, competency-evaluation, training, and residency. Additionally, 19 medical schools across the country have signed the Trump administration’s Nutrition Education Pledge, vowing to incorporate 40 hours of nutritional education or its competency equivalent into graduation requirements starting this fall.
    • “Poor diets are the primary driver of America’s chronic disease epidemic, and today’s announcement reflects the shifting landscape toward placing nutrition and prevention at the core of patient health,” said Secretary Robert F. Kennedy, Jr. “Still, more work remains, and I look forward to seeing nutrition play an increased role as the latest science, data, and best practices develop.”
    • “Last August, HHS and the Department of Education sent a letter to medical organizations encouraging them to improve their standards and place nutrition at the core of their programs.”
  • Beckers Hospital Review informs us,
    • “TrumpRx.gov is adding 160 prescription drugs to the platform, bringing its total to more than 800  according to a June 5 Truth Social post from President Donald Trump.
    • “The president said the expansion would allow TrumpRx.gov to offer discounted pricing for medications that account for roughly four out of every five prescriptions filled in the U.S. The administration also claims the platform has saved American patients more than $400 million since its February launch.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced additional leading technology companies have committed to partnering with the US Tech Force (Tech Force), the government-wide initiative to recruit top technologists to modernize the federal government and strengthen America’s technical workforce.
    • “The new industry partners include Arista Networks, Armada, Cisco, Cognition AI, Cognizant, Payward, Moveworks from ServiceNow, Scale AI, and Wiz.
    • “These companies will contribute to Tech Force by providing technical training resources, executive engagement and programming, nominating employees for temporary government service, and helping create paths for Tech Force alumni into the private sector.” * * *
    • “More information about Tech Force is available here.”
  • The American Hospital Association News reports,
    • “The Drug Enforcement Administration today released a final rule implementing provisions from the Restoring Hope for Mental Health and Well-Being Act of 2022, which passed as part of the Consolidated Appropriations Act of 2023, eliminating the need for a separate waiver for qualified practitioners to dispense certain types of controlled substances for medications for opioid use disorder treatment, or MOUD. While the original requirements were amended by the SUPPORT Act of 2018 and changes were implemented in an interim final rule in 2020, the 2022 legislation struck the amended section from regulation, thus requiring DEA to respond to public comments on the interim final rule and update regulatory language accordingly.”

From the Food and Drug Administration front,

  • Fierce Pharma informs us
    • “The FDA has expanded the label for Pfizer’s subcutaneous hemophilia drug Hympavzi, now including patients age 6 and older who have hemophilia A or B.
    • “The anti-tissue factor pathway inhibitor was initially approved in October of 2024 for those age 12 and older with hemophilia A or B who have not developed the antibodies—also known as inhibitors—produced by the immune system that block or destroy infused clotting factor medications.
    • “The new expansion covers all patients 6 and older, regardless of their inhibitor status. The new nod also opens up the treatment to those 12 and older who have developed the inhibitors.”
  • CBS News reports,
    • “Retatrutide isn’t supposed to be everywhere.
    • “Touted as the next generation in the GLP-1 craze, it’s an experimental weight-loss drug that is not authorized outside of clinical trials. The Food and Drug Administration hasn’t reviewed whether it is safe and effective, which is the legal path for prescription drugs to come to market. And yet retatrutide is for sale all over the internet, a phenomenon with no modern precedent.
    • “It isn’t just shadowy online vendors offering what they claim to be research-grade retatrutide.
    • “A CBS News investigation found dozens of clinics across the country, staffed by licensed physicians and nurse practitioners, openly advertising retatrutide. That practice defies a longstanding norm in medicine – to wait for the FDA to approve a drug before prescribing it – and is contributing to a booming commercial marketplace for a drug that is barred from sale by federal law.” * * *
    • “It’s on the states to really police this kind of conduct,” said Nathan Cortez, a professor at SMU Dedman School of Law, adding that they often lack enforcement resources. “At some point it becomes so blatant and widespread that, you’re wondering, ‘What are we doing here? Are we going to enforce the law or not?'”
  • The Wall Street Journal adds,
    • Eli Lilly LLY shares rose in early European trade after a late-stage trial showed its drug was effective in weight loss and in alleviating obesity-linked conditions.
    • “Shares jumped 4.4% premarket to $1,181, extending a record high hit at Friday’s market close. The stock is up over 30% since the Indiana-based company reported first-quarter earnings on April 30.
    • “Participants in a Phase 3 trial of retatrutide—an experimental drug targeting obesity-related hormones—showed substantial weight loss, with those taking 12 mg doses losing an average of around 70 pounds over an 80-week period, the company said.
    • ‘One-third of participants on 12 mg doses saw their weight fall into a healthy weight range, while two-thirds fell below the threshold for obesity, Eli Lilly said.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Massachusetts June 8 vacated the $100,000 fee for new H-1B visas established by a proclamation in September 2025. Judge Leo T. Sorkin declared the fees unlawful and said in his decision that it “exceeds the fee-setting authority delegated by Congress.” The AHA last year asked the administration to make healthcare personnel exempt from the fees. The federal government is likely to appeal the June 8 decision.”

Reports from the American Diabetes Association’s annual meeting,

  • Fierce Pharma adds,
    • “With an obesity green light already in hand, Eli Lilly is pushing for its newly launched Foundayo (orforglipron) to break into Type 2 diabetes, in turn rounding out its oral offering in line with Novo Nordisk’s duo of GLP-1 pills in both indications. 
    • “Now, in results from a trio of pivotal phase 3 studies presented Monday at the American Diabetes Association 2026 Scientific Sessions, Lilly is aiming its diabetes data squarely at two of the oral GLP-1’s biggest potential rivals.
    • “Sure to grab the most attention at the conference are results from Achieve-3, a head-to-head trial in which Foundayo topped Novo’s oral semaglutide on metrics of blood sugar reduction and weight loss in T2D patients.” 
  • STAT News notes,
    • “AstraZeneca’s investigational GLP-1 pill showed promise in mid-stage obesity and diabetes studies, but it may still be too early to determine how it stacks up against oral treatments already on the market.
    • “In one Phase 2 trial of people with obesity, called VISTA, those on the highest dose of the drug, called elecoglipron, lost 11.2% of their weight after 36 weeks, when looking at all patients regardless of discontinuations, according to data presented Monday at the annual meeting of the American Diabetes Association and published in the Lancet. (Eli Lilly’s pill Foundayo led to the same rate of weight loss in a Phase 3 study that lasted twice as long, but it’s hard to compare across trials in different phases.)”
    • “In a separate Phase 2 trial in people with diabetes, called SOLSTICE, patients on the highest dose saw up to a 1.74 percentage-point decrease in a measure of blood sugar called A1C after 26 weeks. The study, also published in the Lancet, enrolled people taking oral Ozempic open-label as a comparator group, and they experienced a smaller A1C decrease of 1.32 percentage points.”
  • The American Journal of Managed Care relates,
    • “A trio of studies presented at the American Diabetes Association 2026 Scientific Sessions has reframed the conversation of diet during pregnancy, pointing to diet quality, not just quantity, as a meaningful lever for managing gestational glycemia and postpartum metabolic risk. This is a conversation that has long been viewed through the narrow lens of weight gain and fetal growth.
    • “Across hundreds of pregnancies, researchers of 3 oral presentations found that higher intake of fiber, nonstarchy vegetables, and plant protein were independently associated with lower continuous glucose monitor (CGM) readings,1 while lower-carbohydrate diets in women with gestational diabetes improved glycemic control but raised micronutrient concerns.2 Perhaps most strikingly, women randomly assigned to a higher-complex carbohydrate diet during pregnancy still showed measurably lower postpartum glucose responses 2 months after delivery, suggesting that what a pregnant woman eats may matter long after the birth.3
    • “Together, these findings challenge prevailing assumptions about optimal gestational nutrition and open new questions about how prenatal dietary interventions might be designed to protect both mother and child over the long term.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Tango Therapeutics said Monday its experimental drug vopimetostat showed promise in a small trial in pancreatic cancer, with nearly all of the enrollees followed so far responding to a regimen that combined its medicine with Revolution Medicines’ closely watched treatment daraxonrasib.
    • “The data suggest vopimetostat outperformed daraxonrasib alone in a similar population of people whose disease had progressed after at least one treatment line and exceeded Wall Street expectations. The company plans to initiate a Phase 3 trial later this year testing the combination.” 
  • The American Medical Association lets us know what doctors wish their patient knew about diverticulitis.
    • “Diverticulitis can turn silent colon pouches into painful inflammation. But plenty of interventions are available, depending on severity of diverticulitis.”
  • Per a National Institutes of Health news release,
    • “By inducing specific patterns of activity in small portions of the brain in awake mice, researchers supported by the National Institutes of Health (NIH) have triggered a recalibration of neural connections that normally only occurs during sleep. This new approach offset the effects of sleep deprivation in memory tasks and revealed features of sleep that are key to its restorative effect.
    • “What we’re essentially doing is forcing sleep in a local region of the brain. While that part is solidifying memories and restoring learning capacity, other parts stay aware/vigilant and connected to environment,” said corresponding author Chiara Cirelli, M.D., Ph.D., a professor of psychiatry at the University of Wisconsin-Madison. “Dolphins do something similar, sleeping with only one brain hemisphere at a time.”
    • “Non-rapid eye movement (NREM) sleep, which makes up about 80% of sleep for adults, is when the junctions between neurons that make memories are evaluated. During this phase, the brain protects important connections for long-term storage, prunes those that are less necessary, and makes space for new ones.”
  • Genetic Engineering and Biotechnology News relates,
    • “A study tracking thousands of B cells across more than 100 germinal centers (GCs) in mice has revealed how the system consistently produces highly effective antibodies. The findings overturn longstanding ideas about how germinal centers function, revealing that they are far more selective than once thought, and challenge the idea that antibody improvement is driven mainly by rare growth “bursts” among the most successful B cells. The discovery could have implications for immune cell evolution, and ultimately guide the design of vaccines against rapidly mutating pathogens like influenza. It could also lead to new ways of studying evolution itself.
    • “The traditional, mechanistic view of germinal centers is to think of them as selection machines sorting out the best antibodies,” said research lead Gabriel D. Victora, PhD, head of the Laboratory of Lymphocyte Dynamics at The Rockefeller University. “But when you look very, very closely, you see a process that’s almost essentially random—a little bit better than a coin toss—which repeats many times until the immune system arrives at the right answer consistently. That’s much more akin to how evolution operates than the way a machine does.”
    • “Victora and colleagues reported on their findings in Cell, in a paper titled “Replaying germinal center evolution on a quantified affinity landscape.”
  • Medscape points out,
    • “Metabolic-bariatric surgery (MBS) in patients aged 65 years or older resulted in long-term meaningful weight loss and remission of obesity-related conditions, although complication rates of about 8% were noted.”
  • The Cancer Therapy Advisor notes,
    • “Hyperthyroidism may be associated with an increased risk of breast cancer, particularly premenopausal breast cancer, according to research published in Cancer Epidemiology, Biomarkers & Prevention.
    • “Findings from in vitro studies have indicated that thyroid hormones can have estrogen-like effects. That suggests that thyroid hormones may affect cellular proliferation of breast tissue and subsequently increase breast cancer risk in people with hyperthyroidism, researchers explained. In this study, the researchers assessed the effects of hyperthyroidism and hypothyroidism on incident breast cancer in women from the Sister Study.
    • “Women diagnosed with hyperthyroidism or receiving related treatment may have elevated BC [breast cancer] risk, particularly premenopausal BC,” the researchers concluded. “Although more research is needed, premenopausal women treated for hyperthyroidism may benefit from enhanced breast cancer screening.”

From the U.S. healthcare business and artificial intelligence front,

  • Fierce Healthcare reports,
    • “Medicare Advantage insurer Essence Healthcare is continuing to build out its partnership with Oura and has unveiled a new clinical program that aims to identify potential sleep apnea risk.
    • “Essence is rolling out a new clinical workflow that will arm physicians with insights into patients’ nighttime breathing habits to identify those who may be at risk for obstructive sleep apnea. The insurer offers the ring as a covered benefit through some of its plans and has been working with Oura’s team to identify more clinical applications for its data.
    • “News of the partnership expansion was shared first with Fierce Healthcare.
    • “Through the program, insights into members’ sleep, as identified by the Oura Ring, will be shared with Essence with the patients’ consent. The insurer then uses Lumeris’ Tom platform to reach out to at-risk individuals and guide them through STOP-BANG, a common evidence-based screening for sleep apnea.”
  • and
    • “Artificial intelligence is here to stay in healthcare, and the industry’s largest players, like CVS Health, are making huge commitments to the tech.
    • “But embracing AI requires a workforce that’s ready for the revolution. With that backdrop, CVS has rolled out its internal AI Learning Academy, which aims to educate its workforce on practical applications for the technology and how it can impact and improve their workflows.
    • “The program was built in collaboration between human resources and tech leaders at the company. Greg Karanastasis, senior vice president for talent and development at CVS, told Fierce Healthcare that the aim was to build something bigger than just a training program.”
  • Per an Institute for Clinical and Economic Research (ICER) news release,
  • MedCity News tells us about “The 3 Biggest Roadblocks to Egg Freezing — and How Providers Are Working to Remove Them.”
    • “Egg freezing has gained popularity as a fertility preservation tool, but experts say high costs, uncertain outcomes and timing challenges continue to deter many women from pursuing it.”
  • MedTech Dive informs us,
    • “Boston Scientific is investing approximately $138 million to build a 500,000-square-foot distribution facility in Plainfield, Indiana.
    • “Indiana Gov. Mike Braun, who announced the project last week, said Boston Scientific will break ground on the facility this year and ultimately create up to 300 jobs. 
    • “Boston Scientific is building the facility to complement its existing distribution network, which includes sites in Georgia, Massachusetts and Minnesota.”
  • BioPharma Dive notes,
    • “Incyte, a drugmaker with a heavy focus on blood diseases and cancers, plans to take control of an experimental medicine that could help control bleeding in a variety of disorders.
    • “Vega Therapeutics, a subsidiary of the “hub-and-spoke” biotech Star Therapeutics, has been developing this “VGA039” medicine primarily as a treatment for von Willebrand disease — the most common inherited bleeding disorder. Now, Incyte has agreed to buy Vega for $1.25 billion up front. Star would be eligible to receive as much as $750 million more if certain sales goals are eventually met.
    • “Patients with von Willebrand disease lack an important clotting protein, meaning that, when they suffer any kind of injury, the bleeding usually takes longer to stop. In severe cases, this bleeding can cause joint or organ damage and be life-threatening. Current preventative treatments include so-called factor replacement therapies given as intravenous infusions two to three times a week. VGA039, meanwhile, comes as a once-monthly, under-the-skin injection that patients can do themselves.”
  • The Wall Street Journal relates,
    • “Roche Holding struck a deal with Nurix Therapeutics NRIX to license an experimental blood-cancer drug for up to $2.3 billion, expanding its pipeline in oncology and potentially other therapeutic areas.
    • The Swiss drugmaker on Monday said it would make an upfront cash payment to Nurix of $700 million, with additional payments subject to the drug, bexobrutideg, reaching development, regulatory and sales targets.
    • Bexobrutideg is due to enter late-stage studies for the treatment of chronic lymphocytic leukemia this summer, Roche said.
    • “The main opportunity for us is in B-cell malignancies. There are many B-cell malignancies and the most dominant of interest for us is chronic lymphocytic leukemia,” Roche’s deputy chief medical officer, Stefan Frings, said in an interview.
    • “The company said the medicine has potential to offer higher efficacy and more favorable tolerability than established therapies for leukemia. The drug is a so-called BTK degrader designed to remove the BTK enzyme from cells, rather than blocking its effects, and overcome resistance.”
  • and
    • “Johnson & Johnson JNJ  has agreed to buy biotechnology company Firefly Bio for $1 billion in cash in a deal that bolsters the drugmaker’s oncology pipeline.
    • “J&J on Monday said Firefly is developing its proprietary Firelink degrader antibody conjugate platform, for KRAS-driven cancers, which have limited treatment options with survival measured in months.
    • “Mutations of the KRAS gene have long been considered undruggable because the gene’s structure lacks the deep binding pockets most drugs need.
    • ‘J&J said the Firelink platform is a novel approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.”
  • and
    • “Novo Nordisk NOVO.B said prescriptions for its Wegovy weight-loss pill have surpassed three million since launching in early January.
    • “The Danish drugmaker said late Sunday that the pill hit one million prescriptions 12 weeks after reaching U.S. pharmacies and online providers, with a further two million prescriptions achieved in the following 10 weeks.
    • “More than 80% of new prescriptions filled for the Wegovy pill are for patients new to the GLP-1 class of drugs, which the company says indicates that the new oral formulation is expanding the obesity treatment market, rather than replacing existing injectable therapies.”
  • Fierce Pharma adds,
    • “On a weekly basis, total GLP-1 prescriptions were trending downward over the week of June 1, falling 5.7% week-over-week, Citi analysts noted. Other than the continued rollout of Lilly and Novo’s respective weight loss pills, the analysts cited the effect of the Trump administration’s “most favored nation” pricing policies as a key future event that they think could impact total prescriptions.” 

Noteworthy Death

  • AP reports
    • “Harvard University professor Robert Coles, the psychiatrist and Pulitzer Prize-winning author who championed the cause of children grappling with poverty and segregation, has died at 97, his son said Sunday.
    • “The son, also named Robert Coles, told The Associated Press that his father died Thursday at a hospice center in Lincoln, Massachusetts.
    • “The elder Coles was famed for documenting the needs of children, particularly those caught in the crucible of social upheaval. The second and third parts of his five-volume “Children of Crisis” won him a Pulitzer Prize in 1973 for general nonfiction.
    • “In a 1965 Washington Post essay, he wrote that, expecting to find many psychiatric problems among the children of poverty, that instead “I was constantly surprised at the endurance shown by children we would all call poor or, in the current fashion, ‘culturally disadvantaged.’”
  • RIP

Friday Report

David Ermer–CDC, CMS, COVID-19, FDA, HSA, Medical / Rx research, Medicare, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–

Simplicity is a virtue

From Washington, DC,

  • Benefits Link calls to our attention:
    • “Text of IRS Rev. Proc. 2026-24: 2027 Inflation Adjusted Amounts for Health Savings Accounts (HSAs) and Maximum Amount for Excepted Benefit Health Reimbursement Arrangements (HRAs) (PDF)
    • “For calendar year 2027, the annual limitation on deductions under section 223(b)(2)(A) for an individual with self-only coverage under a high deductible health plan [which thereby entitles the enrollee to contribute to a health savings account] is $4,500. For calendar year 2027, the annual limitation on deductions under Section 223(b)(2)(B)for an individual with family coverage under a high deductible health plan is $9,000.
    • “For calendar year 2027, a DPCSA [Direct Primary Care Service Arrangement] is not treated as a health plan with respect to an otherwise eligible individual if the aggregate monthly fees for all DPCSAs with respect to the individual do not exceed $150 or, if the individual is covered by a DPCSA that covers more than one individual, $300.
    • “For calendar year 2027, a ‘high deductible health plan’ is defined under section 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,750 for self-only coverage or $3,500 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $8,700 for self-only coverage or $17,400 for family coverage.
    • “For plan years beginning in 2027, the maximum amount that may be made newly available for the plan year for an excepted benefit HRA under Section 54.9831-1(c)(3)(viii) is $2,250.” 
  • Healthcare Dive shares industry reactions to yesterday’s final rule on the No Surprises Act Independent Dispute Resolution process.
    • “No Surprises has largely been successful in that goal, preventing millions of Americans from being hit with unexpected out-of-network charges. But the law came with an unintended consequence, creating a multi-billion dollar industry enabling doctors to get paid significantly more than they normally would for providing care.
    • “This rule is a missed opportunity to restore the balance that Congress intended — a balance that has been badly warped by activist courts and predatory provider interests,” James Gelfand, the CEO of the ERISA Industry Committee, which lobbies on benefits issues for large employers, said in a statement.
    • “Payers and providers have been at odds over independent dispute resolution, or IDR. Each side has long complained that the process unfairly benefits the other.
    • “But over the past few years, data has emerged suggesting that doctors and medical groups are raking in the dough from IDR — filing snowballing disputes, winning an exceptional share of awards and garnering massive payouts.”
  • Per a Department of Health and Human Services news release,
    • “U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today announced a series of major initiatives to strengthen the nation’s response to Lyme disease and other tick-borne illnesses. HHS actions include a multi-million-dollar pilot program focused on tick control, up to $2.5 million in innovation challenges, funding for NIH researchers to combat Alpha-gal syndrome, and a public-private collaboration to help patients connect with experienced providers.
    • “Secretary Kennedy delivered these announcements during a press conference in New Hampshire — one of the states hardest hit by Lyme disease — after convening a roundtable with state lawmakers and Lyme disease advocates as part of his “Take Back Your Health” tour.”
  • The American Hospital Association reports,
    • The Centers for Medicare & Medicaid Services May 28 issued a final rule making changes to the Increasing Organ Transplant Access Model beginning July 1. IOTA is a six-year mandatory model for certain kidney transplant hospitals that began July 1, 2025. CMS finalized its proposal to raise the low-volume threshold from 11 kidney transplants performed annually during each of the baseline years to 15. The agency also finalized its proposal to include Medicare Advantage beneficiaries in the calculation of upside and downside risk payments. Although CMS considered lowering the maximum upside risk payment to $10,000 per transplant, it will remain $15,000 due to comments in opposition submitted by the AHA and other stakeholders. In addition, CMS adopted requirements for notifying patients of changes in waitlist status; however, in response to many concerns raised by the AHA and other commenters, it did not finalize its proposals regarding notifications of declined organ offers. Finally, in a modification of its original proposal, CMS adopted an updated risk adjustment methodology for performance on the model’s one quality measure that is consistent with the widely used Scientific Registry of Transplant Recipients framework.
  • Fierce Healthcare relates,
    • “Elevance Health has earned a reprieve from potential federal sanctions on its Medicare Advantage plans.
    • “The Centers for Medicare & Medicaid Services sent a letter (PDF) to the company Friday, saying that it has completed key steps to remedy the agency’s concerns. CMS was set to suspend enrollment in Elevance’s MA plans on March 31 if the insurer did not comply.” * * *
    • In Friday’s letter, CMS said the Elevance has completed initial data submissions through the designated channels, and sent a wire transfer for overpayments based on “all auditable estimates” in the case. How much money that amounts to was not disclosed.
    • But despite the good news, the company is not out of the water yet. CMS said it must complete further steps by June 30 to avoid sanctions, as well as tie up any loose ends from previous steps in the process by July 31.
    • Sanctions would be implemented on July 1 if new steps are not met, or on Aug. 1 if these incomplete processes are not resolved, CMS said.

From the Food and Drug Administration front,

  • Cardiovascular Business reports,
    • The U.S. Food and Drug Administration (FDA) is once again warning the public about a safety concern with Johnson & Johnson MedTech’s line of Impella heart pumps. 
    • This latest alert was put in place after the company learned that certain Impella CP sets with SmartAssist “do not meet design specifications” and could experience a low purge pressure event. 
    • “Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support,” according to the FDA’s advisory. “Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.”
    • One patient died as a result of this issue.
  • Fierce Pharma relates,
    • “With a pediatric approval in hand for Afrezza, MannKind believes that it finally has the boost it needs to make an impact in the market after struggling for more than a decade with the inhaled insulin powder.
    • “On Friday, the FDA signed off on an expansion for Afrezza to treat adolescents and children ages 6 and older with Type 1 or Type 2 diabetes. The drug must be used alongside basal insulin in patients with Type 1 disease, according to a May 29 press release. 
    • “The nod comes 12 years after the U.S. regulator cleared Afrezza as a fast-acting, before-meal option for adults with diabetes.”
  • and
    • “Johnson & Johnson has bolstered the psoriatic arthritis (PsA) nod for its IL-23 inhibitor Tremfya in the U.S., picking up an FDA expansion that covers the med’s ability to thwart the progression of structural joint damage in adults with active disease. 
    • “Patients with active PsA can start to suffer joint damage as early as 6 months after the onset of their condition, reinforcing the need for a treatment like Tremfya that can provide daily symptom relief and protection from structural joint damage over the long term, Philip Mease, M.D., of the Swedish Medical Center and University of Washington School of Medicine in Seattle, said in a J&J press release.” 
  • The Wall Street Journal tells us,
    • “Replimune Group REPL said Friday it has reached an agreement with the Food and Drug Administration on a path to resubmit its application for its experimental treatment for advanced melanoma.
    • “It wasn’t immediately clear whether Replimune would submit new clinical data or additional analyses of existing trial results to help secure approval.
    • “The company plans to resubmit the application in the coming days, the company said.”

From the public health and medical / Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “As of May 29, 2026, the amount of acute respiratory illness causing people to seek health care is very low.
    • “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country.
    • “COVID-19 activity is low in most areas of the country.
    • “Seasonal influenza activity is low.”
  • The University of Minnesota’s CIDRAP reports,
    • “The Centers for Disease Control and Prevention (CDC) today confirmed 31 new measles cases in a nationwide outbreak that has now reached 1,983 infections, as experts describe sometimes-serious symptoms that can warrant hospital stays, including brain inflammation and pneumonia. 
    • “All but nine of the US infections are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.” * * *
    • “According to the CDC measles map, South Carolina has recorded the most cases so far this year, at 669, but its outbreak is now over. Utah is next, with 484 cases—although the Utah health department lists 476,just two more than last week. The state recorded eight new cases the previous week and 10 the week before, for a three-week total of 20.
    • “Texas has 182 cases, and Florida 139, four of them new, according to the CDC map.
    • “Fortunately, the outbreak in our region does appear to be slowing,” said Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah. He was part of a media briefing this week sponsored by the Infectious Diseases Society of America (IDSA).”
  • The Wall Street Journal relates,
    • “Trump administration officials are asking states to ensure 24/7 monitoring for [over a dozen] Americans exposed to hantavirus to allow home isolation.
    • “Federal officials require states to issue quarantine orders if people fail to comply, with health officials checking symptoms twice daily.
    • “The World Health Organization recommended a 42-day quarantine for high-risk exposure to the Andes strain of hantavirus.”
  • MedPage Today tells us,
    • “Alzheimer’s pathology appeared as early as midlife and correlated with poorer cognitive performance in a cohort study.
    • “Blood biomarkers identified Alzheimer’s pathology in 6% of middle-age adults.
    • “Baseline pathology predicted steeper 5-year declines in verbal memory and processing speed.”
  • and
    • “Strong preclinical evidence suggested PCSK9 inhibitors may overcome immunotherapy resistance by preventing tumor cells from evading the immune system.
    • “In patients with lung cancer, melanoma, or kidney cancer, use of PCSK9 inhibitors, in addition to immunotherapy, was associated with better survival in this matched-cohort study.
    • “The survival benefit was independent of cardiovascular outcomes, suggesting an alternative biological pathway.”
  • and
    • “Enhanced, abbreviated MRI (AMRI) outperformed ultrasonography (US) as a screen for early liver cancer in high-risk patients with cirrhosis, according to a single-center, randomized clinical trial.
    • “Overall, AMRI yielded significantly more early-to-advanced stage cancer among 759 patients: the per-patient detection rate in Barcelona-Clinic Liver Cancer (BCLC) stage 0, A, B, or C hepatocellular carcinoma (HCC) was significantly greater in those randomized to screening with hepatobiliary-phase image AMRI (HBP-AMRI) using gadoxetic acid than in those screened with US, at 8.5% versus 3.1% (P=0.002).”
  • tctMd informs us
    • “The likelihood that patients with hypertension will stop taking their prescribed blood pressure-lowering medications varies by drug regimen, a meta-analysis of short-term clinical trials suggests.
    • “Combination therapies—particularly angiotensin II receptor blockers (ARBs) paired with calcium channel blockers (CCBs)—generally were better tolerated than monotherapies, researchers reported today in JAMA, and some meds even had discontinuation rates lower than seen with placebo.
    • ‘High blood pressure is notoriously undertreated, something that’s often attributed to the  perceived tolerability, or lack thereof, of antihypertensive drugs. 
    • “Fear of adverse events remains a major reason for undertreatment of high blood pressure, the leading modifiable risk factor for death and cardiovascular disease worldwide. For years, we have assumed that more blood pressure-lowering treatment equates to worse tolerability, and hence most patients are started and remain on single drug monotherapy,” Nelson Wang, MD, PhD (University of New South Wales, Sydney, Australia), told TCTMD in an email.”
  • The Journal of American Managed Care informs us that “Endometriosis Surgery Becomes More Complex With Older Age Despite Plateauing Severity, Study Finds.”

From the American Society of Clinical Oncology conference front,

  • BioPharma Dive reports,
    • “A regimen combining Bristol Myers Squibb’s experimental mutliple myeloma drug mezigdomide with standard therapies delayed disease progression or death about 10 months longer than typical care alone, according to Phase 3 data unveiled Friday at the American Society of Clinical Oncology meeting.
    • “Trial enrollees who got mezigdomide along with Amgen’s Kyprolis and a steroid were 52% less likely to have progressed or died during the trial period compared with people receiving only those two other therapies. Study recruits in the “SUCCESSOR-2” trial had already seen their disease advance after at least one treatment line. Many had previously received two or more therapies.
    • “Mezigdomide is one of two protein-degrading drugs Bristol Myers has already submitted to U.S. regulators and hopes to position as successors to its popular multiple myeloma therapies Revlimid and Pomalyst. The treatment lanscape has become more competitive, though, with the emergence in recent years of cell therapies and bispecific antibodies that are becoming part of early-stage treatment.”
  • and
    • “Merck & Co. has said many new products will be needed to absorb the coming financial impact when its blockbuster cancer medicine Keytruda loses patent protection. One, discovered by China-based Kelun-Biotech and licensed to Merck a few years ago, has now come to the forefront.
    • “Dubbed sacituzumab tirumotecan, or sac-TMT, the therapy is part of a class of “antibody-drug conjugates” drugmakers see as potentially supplanting traditional chemotherapy in many cancers. Merck has been so encouraged by the clinical results it’s seen so far that it’s put the drug into a sprawling Phase 3 program consisting of 17 studies in a range of tumor types.
    • “Sac-TMT “could be one of our cornerstone ADCs, and that’s why you see our conviction in all of these trials,” said Shweta Jain, who oversees Merck’s oncology assets, in an interview with BioPharma Dive.”
  • STAT News adds,
    • “Investors have never really been excited about Pfizer’s Lorbrena, a targeted drug that is the successor to the company’s earlier targeted drug, Xalkori, to treat non-small cell lung cancer that is caused by any of a number of genetic alterations to the gene including ALK and ROS1. For patients, it has been a breakthrough.”
    • “Lorbrena was approved as second- or third-line treatment in 2018, and then as first-line treatment in 2021. Its main benefit over Xalkori is that Lorbrena can penetrate the brain. Non-small cell lung cancer often metastasizes there, but the large size of the earlier molecule meant that patients would have their disease controlled throughout their body, except inside their heads.
    • “Two years ago at ASCO, Pfizer presented data showing that five years out, Lorbrena reduced disease progression by 81% in patients with altered versions of the ALK gene. Today, researchers presented data that are even more remarkable. At seven years, patients had a 55% likelihood of being alive without disease progression, compared to 3% for those who were taking Xalkori. In an interview, Jeff Legos, Pfizer’s chief oncology officer, said that this appeared to be the longest progression-free survival ever reported in metastatic or advanced non-small cell lung cancer.
    • ‘ALK+ non-small cell lung cancer accounts for less than 5% of cases of disease. But in those patients, about a third will develop brain metastases within two years. Lorbrena reduced those metastases by 91% compared to Xalkori.” 

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “UnitedHealth UNH Group plans to stop requiring doctors to get approvals for an array of pediatric procedures, tests and services, further cutting back on a process that has long been detested by physicians and patients.
    • “UnitedHealth, parent of the biggest U.S. health insurer, on Friday said that the changes will eliminate roughly two-thirds of prior-authorization requirements for members under the age of 18 by the end of the year.
    • “UnitedHealthcare said it will stop requiring signoffs for many diagnostic services, routine surgical procedures and specialty care services across pediatric subspecialties such as cardiology, neurology, pulmonology and orthopedics.
    • “The insurer will additionally introduce authorization waivers for certain procedures performed at pediatric hospitals.
    • “UnitedHealthcare said it is conducting a rigorous and data-driven review of all pediatric prior authorization requirements in order to determine which services can be safely removed.”
  • Beckers Payer Issues informs us,
    • “The forces reshaping health plans over the next several years are converging fast. Across the industry, executives and clinical leaders point to three trends that will define which organizations will thrive: the rapid maturation of AI from pilot projects into core operational workflows, the intensifying pressure to make healthcare genuinely affordable, and the rising tide of consumer expectations for transparency, simplicity and personalized care. 
    • “Becker’s asked 16 health plan executives which trend they think will most influence health plans over the next few years.”
    • You can read the exec’s thoughts in the article.
  • Beckers Hospital Review ranks 66 health systems by long term debt.
    • “Long-term debt continues to weigh on health system balance sheets, even as many reported improved operating margins in 2025. Some systems have been actively deleveraging through hospital divestitures, debt refinancings and operational improvements, while others have taken “on new debt to fund capital projects, acquisitions and EHR investments.
    • Highly leveraged systems are looking to sell hospitals, facilities or business lines to reduce leverage and secure long-term sustainability, while systems with stronger balance sheets are using the dislocation to pursue growth through M&A.”
  • Healthcare Dive points out,
    • “The Coalition for Health AI released a series of governance resources this week that aim to help health systems safely roll out artificial intelligence tools. 
    • “The playbooks, developed through community workshops and work groups that included more than 150 clinicians and health AI leaders, provide examples and guidance on implenting AI, including resources on setting up AI policies, managing third party developers and assessing risks. 
    • “The goal is to provide a standardized, but flexible framework that health systems can use to deploy AI tools, regardless of their size or available resources, CHAI said.”

Thursday report

David Ermer–CDC, COVID-19 vaccine, FDA, Generative AI, Medical / Rx research, Mental health care, No Surprises Act, Obesity, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC,

  • The American Hospital Association News reports,
    • “The departments of Health and Human Services, Labor and the Treasury [and the Office of Personnel Management] issued a final rule May 28 intended to improve the functioning of the No Surprises Act (NSA) independent dispute resolution process. The rule streamlines communication between payers, providers and certified IDR entities and clarifies timelines and processes. It improves the functionality of the IDR process by finalizing various changes, including allowing up to 50 items and services to be batched in the same payment dispute. The final rule also increases access to the IDR process by reducing the administrative fees associated with it. The AHA supported many of these changes in comments on the proposed rule.”
  • The rule decreases the federal government fee for handling an NSA arbitration from $115 per party to $15 per party. The FEHBlog expects the arbitrators’ fees to increase accordingly over time. No good deed, etc.
  • The FEHBlog also expected the final rule to include an administrative remedy that would allow providers and payers to enforce or challenge arbitration awards.
  • The FEHBlog agrees with AHIP’s comments on the final rule.
    • “While the focus on addressing flawed incentives in the IDR process is a significant first step, more action is needed to protect Americans from unconscionable price gouging by some PE-backed providers and IDR middlemen.” – Chris Bond, AHIP spokesman”
  • Tammy Flanagan, writing in Govexec, discusses “[w]hat retiring feds should do before asking for help.
    • “Clear timelines, complete records and focused questions can make retirement problems easier to resolve, especially as agencies face mounting workloads.”
  • Federal News Network tells us,
    • “The Postal Service is putting immediate restrictions on nonessential spending to avoid running out of cash sooner than expected.
    • “Postmaster General David Steiner wrote in a memo Tuesday that the restrictions will impact hiring, travel and training as well as other areas of spending. Departments within USPS may be asked to provide a summary of “cost-containment actions taken and expected savings.”
    • “Steiner told members of the House Oversight Committee in March that USPS will run out of cash in early 2027, as long as it continues to pay its bills on time. But USPS is relying on some emergency measures to conserve cash.
    • “As you are aware, we are currently experiencing a temporary cash-flow shortage that requires us to take decisive steps to manage our available resources responsibly,” Steiner wrote in the memo. “To protect core operations and ensure that we can continue meeting all essential obligations, we are implementing immediate restrictions on non-essential spending across all departments.”

From the Food and Drug Administration front,

  • MedPage Today reports,
    • “The FDA’s vaccine advisors voted 8 to 0, with one abstention, in favor of a monovalent XFG vaccine for COVID-19 shots for the 2026-2027 season.
    • “The Vaccines and Related Biological Products Advisory Committee (VRBPAC) also discussed the need to target the long-simmering BA.3.2 variant, also known as “cicada,” though most expressed confidence that targeting XFG was the right way to go.
    • “The XFG variant is the most common variant in the U.S. right now, and looking at the other JN.1 variants that may be coming up, I still think that the BA.3.2 variant is not as common. I think we have to keep surveillance very vigilant though,” said Anna Durbin, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore, adding that the “immunogenicity of the vaccines looks good, so I was very comfortable voting yes.”
  • Fierce Pharma relates,
    • “AstraZeneca has fired another volley in its bladder cancer competition with Merck’s Keytruda, with the FDA on Thursday clearing its PD-L1 inhibitor Imfinzi as part of the first immunotherapy combo regimen in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who haven’t previously received standard of care Bacillus Calmette-Guérin (BCG) treatment. 
    • “The green light clears Imfinzi in the indication alongside BCG induction and maintenance therapy, AZ said in a May 28 release. 
    • “This marks the second recent bladder cancer nod for Imfinzi, which was approved in March of last year in muscle invasive bladder cancer (MIBC), in that instance in combination with the chemotherapies gemcitabine and cisplatin ahead of bladder-removing surgery and then on its own following the procedure.”
  • and
    • “As AbbVie continues to capitalize on its ImmunoGen deal, the growth of commercial antibody-drug conjugate (ADC) Elahere, another of the acquired company’s clinical assets has crossed the FDA finish line. 
    • “The FDA on Wednesday announced the approval of AbbVie’s CD123-direct ADC pivekimab sunirine-pvzy, which will hit the market under the Decnupaz moniker, as a treatment for adults with the rare blood cancer blastic plasmacytoid dendritic cell neoplasm (BPDCN). 
    • “The condition is a rare and aggressive cancer of the bone marrow and blood that can also affect organs like the lymph nodes, spleen and skin. Most patients with BPDCN present with purple-colored skin lesions and the malignancy is often diagnosed in more men than women, with most patients aged 60 years and older.” 
  • Health Exec tells us,
    • “The U.S. Food and Drug Administration (FDA) said it’s aware of an issue with IV tubes, where black matter has been found within the walls of the plastic walls, signaling a contamination issue.
    • “ICU Medical said samples containing the particulates are being returned for analysis to help identify the problem. Until then, the devices are being removed from use and distribution.
    • “Typically sterile, these tubes are used to connect medication and fluid bags to patients, as administered through an IV line.
    • “ICU Medical and the FDA said in an announcement this could be a potentially high-risk issue, though there was no mention of patient injuries. The FDA described the notice as an early alert regarding a potential safety issue.”

From the judicial front,

  • Modern Healthcare reports,
    • “Clover Health won a lawsuit [in the U.S. District Court for the Southern District of Georgia] challenging its 2026 Medicare Advantage star ratings.
    • “A federal court ruled that 20 quality measures the Centers for Medicare and Medicaid Services used are improper.
    • “The decision could have industrywide implications because CMS rated all Medicare Advantage insurers on those metrics. 
    • “CMS filed a motion to reconsider the ruling.

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention today released a report highlighting data on patients hospitalized during a 2025 measles outbreak centered in West Texas. There were 762 confirmed cases during the outbreak, which lasted from late January through mid-August 2025. The report found that of the 60 hospitalized patients, nearly 91% were children and adolescents under age 18 and nearly 56% were age 4 or younger. Additionally, 4 out of 5 hospitalized adults age 18-44 were pregnant women in their third trimester. Available medical records of 54 patients were reviewed. All 54 were found to be unvaccinated or had an unknown vaccination status.”
  • Healio relates,
    • “Measures of ideal heart health including healthy levels of physical activity, BMI, BP and sleep were associated with lower risk for severe COVID-19 among people with no history of heart disease during the pandemic, researchers reported.
    • “For every 1 standard deviation increase in total American Heart Association’s Life’s Essential 8 score, individuals without prior CVD experienced an approximately 20% reduced risk for severe COVID-19 infection, according to data published in the Journal of the American Heart Association.”
  • Health Day adds,
    • “Being incredibly fit shouldn’t increase a young adult’s risk of dangerous irregular heart rhythm, a new study says.
    • “Young male athletes and fitness buffs aren’t more likely to develop atrial fibrillation, despite earlier studies that showed an apparent link, researchers reported May 21 in the journal Circulation.
    • “Our study shows that there are good reasons to nuance and tone down the message, which has been widespread at times, that high levels of fitness or participating in races would pose a big risk to a person’s cardiovascular health,” said lead investigator Marcel Ballin, an associated researcher at Uppsala University in Sweden.
    • “The risk of atrial fibrillation is certainly not zero, but that said, the benefits are significantly greater,” he said in a news release.”
  • and
    • “Adopting low-insulinemic and planetary health diets during menopause is associated with optimized weight management, according to a study published online May 20 in JAMA Network Open.
    • “Tong Xia, M.D., Ph.D., from Brigham and Women’s Hospital in Boston, and colleagues compared dietary patterns and their associations with weight gain and obesity risk in the years surrounding menopause. The analysis included 38,283 women participating in the Nurses’ Health Study II, with 12-year observations surrounding menopause.
    • “The researchers found that after adjusting for age, race and ethnicity, marital status, income, postmenopausal hormone therapy use, parity, smoking, alcohol, energy intake, physical activity, and baseline body mass index, the reverse empirical dietary index for hyperinsulinemia (EDIH; quintile 5 versus 1) was associated with the largest reduction in weight gain (mean, −0.28 kg/year). The lowest risk for incident obesity was seen with the Planetary Health Diet Index (PHDI; hazard ratio, 0.46) and reverse EDIH (hazard ratio, 0.51). The largest positive correlations in the EDIH were seen with red or processed meats, sodium, and French fries, while for the PHDI, the largest positive correlations were seen with nuts, unsaturated fats, whole-grain carbohydrates, and vegetable protein.” 
  • The Washington Post informs us,
    • Ozempic was supposed to be a gut story. Then Allison Shapiro looked at the brain scans.
    • An assistant professor at the University of Colorado Anschutz, she was part of a team studying 13 teens and young women with a hormonal disorder affecting the ovaries who were put on GLP-1 drugs. As part of testing to catalogue the effect of the medication on their bodies, Shapiro took snapshots of their brains before and after.
    • She was astonished to find extensive changes.
    • Within only a few months, the brain connections in the salience network, which helps target attention, had multiplied.
    • “We didn’t expect to see this effect, and we really don’t know what it means,” Shapiro said.”

  • BioPharma Dive tells us,
    • “An RNA-based shot developed by GSK and Ionis Pharmaceuticals helped wipe out hepatitis B in about a fifth of the patients who received it in a pair of clinical trials, according to study results published Thursday in the New England Journal of Medicine.
    • “Called bepirovirsen, the shot could represent an important advance for people with chronic hepatitis B infections, less than 1% of whom can achieve such a “functional cure” with the help of oral antivirals. None of the participants who received a placebo hit that mark in the two trials presented Thursday.
    • ‘The Food and Drug Administration is already reviewing an approval application for bepirovirsen, and has granted the drug “fast track” and “breakthrough therapy” designations that could speed up its evaluation. An approval decision is expected no later than Oct. 26.”
  • Genetic Engineering and BioTechnology News points out,
    • “Biohub, the non-profit research organization co-founded by Priscilla Chan, MD, and Mark Zuckerberg, has now unveiled the latest update to the ESM protein language model family, with expanded capabilities in binder design and protein function mapping for therapeutic discovery. The release comes just seven months after Biohub recruited the team behind EvolutionaryScale. 
    • “The system includes ESMC (Evolutionary Scale Modeling Cambrian), a language model trained on approximately 2.8 billion sequences drawn from a breadth of life, including organisms adapted to extreme environments, and more than 20,000 types of proteins found in the human body. Evolutionary information encoded in ESMC is translated into atomic-resolution protein structures and interactions using the design engine and prediction model, ESMFold2. 
    • “Alex Rives, PhD, head of science at Biohub and former chief scientist at EvolutionaryScale, presented the work at this week’s “AI in Biology” symposium at Cold Spring Harbor Laboratory.  
    • “These models aim to transform the earliest stages of drug discovery by making biology more programmable. While traditional discovery workflows rely on slow and resource intensive experimental screens to identify promising drug candidates, rational protein design guided by in silico predictions has the potential to dramatically accelerate development timelines. 
    • “We’re at an exciting point in protein biology where accurate digital representations allow asking experimental questions at a scale that wouldn’t be possible in the laboratory,” Rives told GEN Edge.”  

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Highmark Health recovered in the first quarter after reporting losses last year, the health system and insurer announced Thursday.
    • “The Pittsburgh-based nonprofit company reported a 1,308% jump in first-quarter net income to $183 million and a 1,340% improvement in operating income to $216 million. Revenues grew 3.8% to $8.3 billion. Highmark Health lost $175 million in 2025.
    • “Highmark Health Plans’ strategic adjustments in Medicare and Medicaid drove the rebound, Highmark Health Chief Financial Officer and Treasurer Carl Daley said.” 
  • Fierce Pharma relates
    • “The top pharmacy benefit manager (PBM) in the U.S., CVS Caremark, will restore coverage to obesity products from Eli Lilly, allowing a significant number of patients to gain access to the drugs through their existing insurance.
    • “CVS will begin covering Lilly’s GLP-1 pill Foundayo on Monday of next week, June 1, while coverage of Lilly’s injected treatment Zepbound begins on October 1. CVS Caremark, which is the pharmacy chain’s drug benefits unit, is the largest PBM in the country.”
  • and 
    • “CVS Health is growing its partnership with Salesforce, leveraging its agentic AI-driven Agentforce Health to boost personalization in its call centers.
    • “The companies announced on Thursday morning that the platform will connect data across CVS, including Aetna and Caremark, to make it easier for call center teams to address a member’s unique needs in a single interaction when possible.
    • “The Agentforce tool will surface critical insights to call center teams in advance, preparing them more effectively for conversations. The goal, the partners said, is to improve the experience for both the member and the workers through a more streamlined interaction.”
  • OptumRx, writing in Linked In, discusses the four drug classes that drive spending.
    • Inflamatory conditions drugs,
    • Oncology drugs,
    • Diabetes drugs, and
    • Obestty Drugs.
  • Beckers Payer Issues points out,
    • “CVS Health’s insurance branch will roll out “Aetna Mental Health On Demand” in 2027, the company said in a May 28 news release.
    • “Aetna members who are at least 13 years old will be able to access licensed clinicians via chat, phone or video. These professionals are trained on a “single-session intervention model” to drive immediate impact, such as through crisis management. Clinicians can provide a personalized plan, advocate for members, connect them with more resources and help with follow-ups and further care coordination.
    • “The platform also contains integrated AI tools for note-taking and administrative tasks. Clinicians participated in hundreds of chats and were able to respond to members within 13 seconds, the news release said about an initial rollout.” 
  • Healthcare Dive tells us,
    • “Teladoc Health said Thursday it is partnering with Walmart to add its virtual care services to the retail giant’s digital healthcare platform.
    • “With the partnership, Teladoc’s virtual care offerings — including urgent care, dermatology and nutrition support — are now available through Walmart’s Better Care Services platform, which connects customers to third-party digital health providers. 
    • “The deal should put Teladoc’s services in front of more potential patients, Kelly Bliss, president of the company’s U.S. group health business, told Healthcare Dive. “We have the largest nationwide network of virtual care providers in the country, and so we want to activate that network and our clinical services wherever people are making health decisions,” she said.”
  •  and
    • “Amazon’s healthcare leader is stepping down from this summer, and the co-founder of telehealth company Amwell will replace him, the retail and technology giant said Wednesday. 
    • “Neil Lindsay, who became senior vice president of Amazon Health Services in 2021, is leaving to pursue personal projects, he said in a message to Amazon employees.
    • “Dr. Roy Schoenberg, the former co-CEO of Amwell who helped found the telehealth provider two decades ago, will start as new head of Amazon’s health business on July 1. Lindsay will stay on as an advisor to Schoenberg through the end of the year.”
  • Per MedTech Dive.
    • “Ōura plans to roll out a swath of health and wellness features in June, following the launch of its latest smart ring.
    • “Among the new additions will be a tool to track nighttime blood pressure patterns and the ability to view nighttime breathing data over a 30-day period. Ōura announced the features, along with its Ōura Ring 5, on Thursday.
    • “Jason Russell, vice president of consumer software product at Ōura, told MedTech Dive that the blood pressure feature is intended to show trends in overnight changes and the relationship to daily habits, such as sleep, stress and exercise. 
    • “Ōura plans to offer blood pressure signals as a wellness feature, meaning it would not be regulated as a medical device, but there are some limitations on what it can tell users.”  

Midweek update

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

Medium adds, “Simplicity, though not traditionally viewed as a virtue, is the greatest virtue of all because it makes practicing every other virtue that much easier.”

From Washington, DC,

  • Healthcare Dive reports,
    • “Senate Democrats are trying to roll back a pilot program that adds artificial intelligence-backed prior authorization for some services in Medicare. 
    • “Sens. Ron Wyden, D-Ore., Maria Cantwell, D-Wash., Richard Blumenthal, D-Conn., and Kirsten Gillibrand, D-N.Y., introduced a resolution Wednesday that would invoke the Congressional Review Act — a legislative tool lawmakers can use to overturn agency actions — to end the WISeR model, which went into effect in six states this year. 
    • “Democrats have railed against the pilot for months, arguing the model delays or denies Medicare beneficiaries’ care. “Americans are sick and tired of abusive prior authorization tactics putting needed health care out of reach,” Wyden said in a statement. “The last thing seniors need is even more AI denying the care they need.”
  • The American Hospital Association relates,
    • “The AHA May 20 provided comments to the House Energy and Commerce Subcommittee on Health for a hearing on the physician fee schedule, the Medicare Access and CHIP Reauthorization Act and potential payment reform. The AHA highlighted responses to previous congressional requests for information on reform to MACRA and physician payments. They include asking Congress to provide conversion factor updates for the physician fee schedule that reflect changes in input costs and inflation, and to improve cost measures used in the Merit-based Incentive Payment System. The AHA also outlined policy considerations for alternative payment model design, advanced APM participation incentives and accountable care organizations.” 
  • STAT News tells us,
    • “Health secretary Robert F. Kennedy Jr. has elevated a senior health official to serve as an interim surgeon general until that position is filled by a Senate-confirmed nominee. 
    • “Stephanie Haridopolos, a family medicine physician who is currently a senior adviser and chief of staff for the Office of the U.S. Surgeon General, is now the office’s director of health communications, Kennedy told staff in an email sent late Tuesday. According to that email, Assistant Secretary for Health Brian Christine used his “delegation of authority powers” to allow Haridopolos to carry out the duties of surgeon general. 
    • “She will “promote [U.S. Surgeon General] public health actions, advisories, and guidance until our next Surgeon General is sworn into office,” Kennedy said.”
  • An HHS news release adds,
    • “The U.S. Department of Health and Human Services (HHS) Office of the Surgeon General today released the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents, which raises national awareness about the growing risks associated with excessive and harmful screen use among young people.
    • “Children and adolescents now spend as much or more time on screens as they do sleeping or in school. National estimates show that adolescents average seven to nine hours a day on entertainment screens, and most report using their devices right before bed. What they encounter online and the excessive, and sometimes compulsive, use of screens is increasingly linked to real-world harm.” * * *
    • The Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents is available at https://www.surgeongeneral.gov. Additional resources for families, schools, and communities are available here.
  • Govexec informs us,
    • “Federal employee morale dropped last year, as President Donald Trump downsized and otherwise overhauled the civil service, according to a new data analysis from Gallup. 
    • “[A]fter the reforms took effect, federal workers experienced declines in employee engagement and job satisfaction, alongside increases in burnout and job-search activity,” the researchers wrote. “These shifts were larger than those observed among comparable state and local government workers — and private sector counterparts — during the same period.”
    • “The analytics firm noted, however, that the data shows there was a “rebound” in some areas by the end of 2025.” 
  • Per a Centers for Medicare and Medicaid Services news release,
    • “The Centers for Medicare & Medicaid Services (CMS) proposed today a sweeping crackdown on state Medicaid payment practices that have driven payment rates well above Medicare levels, leading to excessive federal costs. The Medicaid Managed Care State Directed Payments (SDP) and Medicaid Fee-for-Service (FFS) Targeted Practitioner Payments Proposed Rule would set clear caps and better align Medicaid payments with Medicare standards. If finalized, the proposed rule would generate an estimated $775 billion in total savings over 10 years, including $510 billion in federal savings. Our goal: to refocus Medicaid dollars on individuals and families instead of inefficient payment schemes.
    • “The proposed rule would:
      • “Cap SDP provider payment rates at 100% of Medicare payment rates for expansion states and 110% of Medicare payment rates for non-expansion states (or 100% of the Medicaid state plan rate if a comparable Medicare rate is not available), consistent with section 71116 of the WFTC legislation and historical Medicaid FFS payment levels,
      • “Apply similar limits to certain targeted Medicaid fee-for-service payments, and
      • ‘Establish consistent national standards to improve transparency and accountability.
    • “CMS is seeking public comment on the proposed rule, including feedback on implementation. “To view the proposed rule on the Federal Register, visit: https://www.federalregister.gov/d/2026-10292. 
    • “To view the fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/medicaid-managed-care-state-directed-payments-medicaid-fee-service-targeted-medicaid-practitioner“

From the Food and Drug Administration front,

  • BioSpace reports,
    • “No child deaths were directly linked to COVID-19 vaccines, according to the FDA’s long-awaited analysis of adverse events.
    • “Late last year, former CBER director Vinay Prasad claimed in a leaked internal memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The FDA, after much blowback from the industry and independent experts, promised to disclose its analysis by the end of 2025, but the agency largely kept its specific findings under wraps.
    • “Those findings were made publicly available last week as part of a letter from Sen. Ron Johnson (R-WI) to health secretary Robert F. Kennedy, Jr., seeking for greater transparency around the safety of COVID-19 vaccines.”
  • Fierce Pharma relates,
    • “Patrick Soon-Shiong’s ImmunityBio has convinced the FDA to weigh its case for a potential expansion of its bladder cancer med Anktiva, citing “overlapping features” in the indication it’s targeting with the interleukin-15 agonist’s existing approval. 
    • “The FDA has now accepted ImmunityBio’s application for Anktiva plus the Bacillus Calmette-Guérin (BCG) vaccine in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA has set a target decision date of Jan. 6, 2027, ImmunityBio said in a May 19 release.” 

From the public health and medical / Rx research front,

  • The American Hospital Association News reports,
    • “The Centers for Disease Control and Prevention yesterday issued an advisory on the Ebola disease outbreak in the Democratic Republic of the Congo and Uganda. The agency said the risk of spread to the U.S. is currently considered low. The notice includes recommendations for clinicians and guidance for U.S. travelers visiting DRC or Uganda. The World Health Organization declared a public health emergency of international concern May 17 due to the outbreak.” 
  • The Washington Post relates,
    • “Teens averaged over 50 minutes of smartphone use between the hours of 10 p.m. and 6 a.m. on school nights, researchers found, and nearly half of the teens used their phones between midnight and 4 a.m. The majority of that phone use was spent on social media apps like YouTube, Instagram or TikTok, the study found. Others were looking at streaming apps or playing games like Roblox or Clash Royale.
    • “The study, published Monday in the journal JAMA Pediatrics, followed the screen use of 657 adolescents, a cohort with an average age of 15. All are participants in the national Adolescent Brain Cognitive Development Study, which includes a racially and economically diverse sample of children and is the largest long-term study of brain development and child health in the United States. 
    • “Researchers drew data from an app installed on the teens’ phones that passively tracked their screen use patterns, said Jason Nagata, the lead author and an associate professor of pediatrics at the University of California at San Francisco. This is significant because “a lot of prior studies have relied on self-reporting of screen use,” he said, which isn’t as thorough or accurate.” * * *
    • “And the full impact on sleep likely goes beyond the minutes spent staring at a glowing screen, Nagata adds. Social media use in particular “is very emotionally activating,” he says. “There’s a lot of stimulation, and that can make it harder for teens in particular to wind down, even after you’ve turned the phone off.”
  • Genetic Engineering and BioTechnology News tells us,
    • “Researchers headed by a team at Icahn School of Medicine at Mount Sinai have discovered that many gut bacteria use a flexible survival strategy—known as epigenetic “bet-hedging”—to withstand disruptions such as antibiotics and diet changes.
    • “Studying infant and gut microbiomes, the investigators showed that microbes can switch between functional states, rather than relying solely on genetic mutations, to try to survive shifting conditions. While bet-hedging has been observed in disease-causing bacteria, this is the first study to show that it is widespread among the beneficial microbes that make up the healthy human gut.
    • “The findings shed light on a previously hidden layer of microbiome biology and may help explain why probiotics and fecal microbiota transplantation (FMT) produce inconsistent benefits across individuals.
    • “Gang Fang, PhD, professor of genetics and genomic sciences and director of the Center for Genomic AI and Microbiome Medicine at the Icahn School of Medicine at Mount Sinai, is senior and corresponding author of the team’s published paper in Cell Host & Microbe, titled “Epigenetic phase variation in the gut microbiome enhances bacterial adaptation
  • STAT News adds,
    • “While Tippi MacKenzie was a postdoctoral fellow in the early 2000s, she and her lab mates experimented with using the then-new technology of gene replacement therapy to try to treat inherited disorders in mice before they were born. Over and over it worked. They cured mice with hemophilia and mice with tyrosinemia. And the whole time, people kept telling her that gene therapy in human fetuses was just around the corner, just five years away. 
    • “It’s now been 25 years, and such a reality has yet to materialize. But after promising discussions with the Food and Drug Administration, MacKenzie is now closer than anyone’s ever been.
    • “Her team has submitted an investigational new drug (IND) application to the agency seeking approval for a small trial that aims to treat five fetal patients with a rare lysosomal storage disorder. The agency told them they could bypass animal testing, because the safety profile of the vector they plan to use already has been so well characterized by other academics and companies developing gene therapies for kids and adults.
    • “Thinking back on it, of course, you can’t really do in utero gene therapy until the field of adult and pediatric gene therapy has been well established,” MacKenzie said Tuesday at STAT’s Breakthrough Summit West. “So we basically had to wait for everything to catch up.”
  • Per a National Institute of Standards and Technology news release,
    • “My Research Is Working Toward a Pain-Free Mammogram Alternative.”\
      • “A woman in the U.S. has a one in eight chance of developing breast cancer. That’s a scary number, but the good news is that more women are being diagnosed early and surviving than ever before. 
      • “We have a long way to go before low-field MRI becomes a common alternative to mammograms. But my fellow researchers and I will continue to work to make this happen, because all patients deserve a highly accurate and pain-free approach to screening for breast cancer.” 
  • Medscape informs us,
    • “Digital tools can enhance GLP-1 therapy for obesity and diabetes by bridging gaps in patient education and follow-up. However, clinicians must focus on meaningful outcomes and personalized guidance to ensure effective use and adherence.”
  • MedPage Today points out,
    • “Antibiotics are sometimes prescribed for lower back pain when more conventional therapies don’t work, based on some studies showing bacteria in affected spinal discs.
    • “In this randomized trial, no benefit from amoxicillin-clavulanate could be discerned for patients with refractory low back pain and herniated discs at 1 year.
    • “The authors recommended that antibiotics no longer be prescribed for this indication.”
  • Per Healio,
    • “Data collected from a number of clinical trials found that despite recent “buzz,” there is no significant link between GLP-1 receptor agonists and the progression of diabetic retinopathy, according to a speaker.
    • “These medications have been labeled not to be good for patients who have preexisting diabetic retinopathy, but I don’t think that is fair,” Majda Hadziahmetovic, MD, associate professor of ophthalmology at Duke University, said during a virtual presentation at Real World Ophthalmology.“Those conclusions actually came from two main clinical trials, and both of those clinical trials were cardiovascular outcome trials. Diabetic retinopathy and retinal health were just the side effects that they were not looking at very carefully.”
  • and
    • “Self-collection may be as effective as clinician-collected HPV tests and improve screening rates.
    • “But its implementation requires OB/GYNs to first transition [from pap smears] to primary high-risk HPV screening.”
  • Infectious Disease Advisor adds,
    • “Screening recommendations for HCV [hepatitis C] have expanded in recent years to include universal screening among adults, with an emphasis on reflexive testing strategies in which a positive HCV antibody (Ab) result automatically triggers confirmatory RNA testing. This approach is intended to reduce delays in diagnosis and improve identification of patients eligible for treatment. To evaluate how these recommendations have influenced testing practices, researchers conducted a retrospective analysis of HCV testing patterns from 2018 to 2024 within a large US commercial laboratory network.” * * *
    • “Increased adoption of reflexive HCV testing, alongside laboratory stewardship initiatives and updated screening recommendations, has contributed to more complete and timely diagnostic evaluation of HCV infection.”
  • Per MedTech Dive,
    • “Medtronic on Wednesday said two analyses of its Symplicity Spyral renal denervation system, presented as abstracts at the EuroPCR meeting in Paris, showed the procedure significantly reduced blood pressure in patients over three years.
    • “Outcomes after renal denervation for 787 patients who had prior cardiovascular events were evaluated in one study, while the second followed 903 people with severe hypertension.
    • “The analyses, from the global SYMPLICITY registry, add to a growing body of evidence supporting renal denervation, Medtronic said.”

From the U.S. healthcare business and artificial intelligence front,

  • 401k Specialist reports,
    • “While some workers believe they’ll be employed past retirement age, the truth is that some may be forced into an early retirement.  
    • “Findings from the 2026 Annual Retirement Study from the Allianz Center for the Future of Retirement show that over half of Americans (53%) currently have a target age they plan to retire at.
    • “However, the reality is that many depart the workforce earlier than initially expected. While the findings report that 53% of Americans retired on their own schedule, 42% had to retire earlier than planned. In fact, only 5% of retirees surveyed reported leaving their role later than anticipated.
    • “The findings emulate recent research from the Society of Actuaries, which showed that 59% of its respondents retired earlier, and only 6% left the workforce later than planned.
    • “When asked why they exited the workforce earlier, Allianz found that most reasons were beyond the retiree’s control. Common causes included health issues that prevented job performance (30%) and unexpected job loss (21%), while others realized they were financially ready earlier than expected (21%).
    • “Finances, as expected, play a major role when deciding when to retire. Retirees must consider day-to-day costs and inflation numbers, along with necessary expenses like medical expenditures as they age.
  • Fierce Healthcare relates,
    • “Patient collections are playing a bigger and bigger role in health systems’ total revenues, bringing a new focus on the difficulties organizations face in securing timely, or any, payments for their services, a new survey report warns. 
    • ‘The poll of 205 healthcare revenue heads, conducted by healthcare fintech vendor PayZen and the Healthcare Financial Management Association, found that 22% of respondents named patient balances as their top priority, roughly double the 11% rate reported a year prior. Patient balances were a “nearly universal” presence among the respondents’ concerns, also up from the 73% rate of a year prior. 
    • “Commercial revenue remained the respondents’ overall top priority, though the portion who indicated so dipped from last year’s 75% to 62%. Government program revenue also inched upward from 13% to 16%, naming it their top revenue concern.” 
  • and
    • “Maven, a virtual provider for women’s and family health, has launched its direct-to-consumer products featuring a virtual care clinic, a GLP-1 offering and a hormone therapy offering.
    • “They are available through cash-pay for now. The goal is to close gaps between prescriptions and follow-ups that GLP-1s and hormone therapies require. 
    • “In terms of pricing, the GLP-1s start at $150 a month. For the hormone product, there is a $150 1-time fee, which includes two virtual visits, in addition to medication costs. Specialty care visits in the virtual clinic are currently pay-per-visit, though insurance coverage for those is the eventual goal.”
  • BioPharma Dive tells us,
    • “Privately held Mentari Therapeutics plans to hit the public markets through a reverse merger with InMed Pharmaceuticals, creating a combined company focused on antibody drugs that can prevent migraines.
    • “The deal, announced Tuesday, has already received approval from the boards of both parties and is expected to close in the back half of this year. Terms hold that InMed shareholders would own roughly 1.5% of the combined company, which is slated to have a pro forma equity value of about $421 million. Baked into that value is a concurrent private placement that will result in gross proceeds of approximately $290 million.”
  • MedTech Dive informs us,
    • “Medtronic said Wednesday it has agreed to buy SPR Therapeutics, a company making a device that uses peripheral nerve stimulation to treat chronic pain.
    • “Under the terms of the deal, Medtronic would pay $650 million in cash to buy all outstanding equity in SPR Therapeutics. The purchase would add to Medtronic’s neuromodulation business, allowing the company to provide more pain relief options earlier in people’s care.
    • “The deal is Medtronic’s third major acquisition announced so far this year. In March, Medtronic agreed to buy neurovascular technology company Scientia Vascular for $550 million, and in February, the company announced plans to buy CathWorks, which makes tools to help detect coronary artery disease, for up to $585 million. Medtronic closed the CathWorks acquisition in April.”
  • Per Healthcare Dive,
    • Aetna’s chief digital and technology officer on how the insurer is using AI for patient engagement
    • Nathan Frank discusses how the insurer is using AI to engage members, how the company thinks about risks, and the importance of monitoring the tools and soliciting feedback.
  • Per Fierce BioTech,
    • “The big new thing in medtech for 2026 is AI-powered apps and chatbots designed to help patients navigate their laboratory test results. Now, testing giant Labcorp is getting in on the act. 
    • “The company is launching “MyLabcorp,” a mobile app that brings together lab results with AI-enabled features and clinical guideline-based content.
    • “The idea is that this can be viewed on a user’s phone via the app, giving users “additional context about their health and support more informed conversations with healthcare providers,” according to a May 20 statement.” 
  • Per Fierce Healthcare,
    • “Doximity plans to accelerate its spending on artificial intelligence this year as it aims to become a leading AI platform for doctors.
    • “The health tech company plans to up its R&D and compute spend along with more investments in brand marketing and its AI-enabled peer review capabilities, executives said during the company’s recent earnings call for its fiscal 2026 fourth quarter and full year results. The company’s 2027 fiscal year began April 1.
    • “The company plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask (formerly DoxGPT).” 

Monday report

David Ermer–CDC, Electronic health records, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “President Donald Trump on Monday announced that about 600 low-cost generic drugs would be available through TrumpRx.gov, a government website aimed at helping Americans purchase medications at discounted prices. 
    • “By incorporating this massive catalog of low-cost generics at TrumpRx.gov, consumers will now have one source to ensure that they’re getting the lowest possible cost on their prescription,” Trump said in a presentation at the Eisenhower Executive Office Building.”
  • Federal News Network relates
    • “HHS sends RIF notices to dozens of staff it missed during office-wide layoffs last year.
    • “Meanwhile, HHS is looking to convert hundreds of senior positions to a rebranded version of the “Schedule F” classification for federal employees.”
  • Per an HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) today announced a reorganization of its Office for Civil Rights (OCR), the Department’s law enforcement agency charged with enforcing laws protecting civil rights, conscience and religious freedom, and health information privacy and security. The reorganization returns OCR to a program-based structure that aligns OCR’s three critical substantive areas with three distinct subject-matter divisions: the Conscience and Religious Freedom Division, the Civil Rights Division, and the Health Information Privacy, Data, and Cybersecurity Division.
    • “This reorganization restores the HHS Civil Rights Division and the Conscience and Religious Freedom Division and strengthens the Office for Civil Rights’ ability to defend religious liberty, enforce conscience protections, and combat unlawful discrimination,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “Under President Trump’s leadership, HHS will defend these rights with clarity, accountability, and resolve.”
    • “This reorganization reinstitutes a structure that rightly prioritizes civil rights and conscience and religious freedom alongside health information privacy and security,” said HHS Office for Civil Rights Director Paula M. Stannard. “All three areas are deserving of subject-matter expertise and distinct senior executive leadership for OCR to best serve the American people.”
  • The American Hospital Association News adds,
    • “Most hospital outreach laboratories must report private payer clinical diagnostic laboratory data for services furnished during the first six months of 2025 to the Centers for Medicare & Medicaid Services by July 31, the agency announced. This includes Healthcare Common Procedure Coding System codes, associated private payer rates and volume data. CMS previously sent letters to hospitals, which the agency believes have outreach laboratories that are likely required to report their data. CMS also has a guide and other resources for hospital outreach laboratories to determine whether and how they must report.” 

From the Food and Drug Administration,

  • The Wall Street Journal reports,
    • “AstraZeneca AZN said it received U.S. approval for a new hypertension treatment, getting the green light to launch a drug the U.K. pharmaceutical company expects to generate multibillion-dollar annual sales at its peak.
    • “The drug, known until now as baxdrostat, will be marketed under the brand name Baxfendy, the company said Monday. The approval expands AstraZeneca’s cardiovascular, renal and metabolism portfolio shortly after diabetes drug Farxiga—its biggest product in that therapeutic area and the bestselling medicine in the company’s history—went off patent in the U.S.
    • “AstraZeneca said that Baxfendy treats hypertension in a new way by targeting aldosterone, a hormone that raises blood pressure.
    • “Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, said the approval brings a new treatment to a disease that has had little therapeutic progress for the past two decades.”
  • Fierce Pharma relates,
    • “Enhertu’s market conquest is continuing apace. Already tracking at $5 billion in annual sales, the star antibody-drug conjugate from Daiichi Sankyo and AstraZeneca has secured FDA approval to treat early breast cancer, further encroaching on Roche’s Kadcyla territory.
    • “The FDA has simultaneously greenlighted Enhertu for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer, the two companies said Friday [July 15, 2026]. The adjuvant nod came nearly two months ahead of schedule, as the FDA had originally targeted a decision by July 7.”
  • The New York Times tells us,
    • “A California dairy company has issued a recall for five ice cream flavors, warning customers that some tubs may be contaminated with metal.
    • “The company, Straus Family Creamery, recalled some of its organic ice cream, which was sold in 17 states since May 4. It said it ordered the recall because of “the potential presence of metal foreign material,” without giving further details.
    • “The warning applies to its vanilla bean, strawberry, cookie dough, Dutch chocolate and mint chip flavors with specific “best-by” dates in late December 2026.
    • “It did not say how many tubs were affected but said the issue was with a “small number of production runs.”
  • Health Day informs us,
    • “The U.S. Food and Drug Administration (FDA) has approved an AI-powered early warning system to detect sepsis, one of the deadliest infections for hospital patients.
    • “The tool, developed at Johns Hopkins University (JHU), detects sepsis hours faster than doctors. It has already reduced deaths by nearly 20% in dozens of hospitals across the United States, JHU reports.
    • “Pre-suspicion screening is what creates lead time, and lead time is what changes outcomes in sepsis,” said Suchi Saria, director of JHU’s AI & Healthcare Lab. “Once a clinician already suspects sepsis, the clock has been running — often for hours or even days.”

From the judicial front,

  • Bloomberg Law reports,
    • “The US Supreme Court turned away appeals from six pharmaceutical companies seeking to topple the Medicare drug price negotiation program that’s led to billions of dollars in discounts on top-selling treatments.
    • “Making no comment, the justices on Monday refused to hear a variety of constitutional arguments against a program created in 2022 by President Joe Biden’s Inflation Reduction Act. The court rejected separate appeals from units of AstraZeneca Plc, Johnson & Johnson, Bristol Myers Squibb Co., Novartis AG, Novo Nordisk A/S and Boehringer Ingelheim Pharmaceuticals Inc.
    • “The rebuffs leave in force a program the US government said in November will produce a 71% discount on Novo Nordisk’s blockbuster Ozempic and Wegovy drugs for Medicare patients starting in 2027. The Trump administration said that round of discounts, covering 15 drugs, will mean $12 billion in savings compared with 2024 list prices.
    • “The cases at the high court involved the previous year’s negotiated discounts, which covered 10 drugs and took effect in January. The Centers for Medicare and Medicaid Services said in 2024 that the deals would reduce out-of-pocket costs by $1.5 billion this year.”
  • Per a Justice Department news release,
    • “A New York man was sentenced today to 37 months in prison for conspiring to launder nearly $1.5 million in illicit health care fraud proceeds through multiple domestic and global banks on behalf of a Transnational Criminal Organization (Organization).
    • “According to court documents, Elnar Zarbailov, 42, of Staten Island, New York, and dual citizen of the United States and Azerbaijan, was a fixer and money launderer for the foreign-based  Organization that spearheaded the largest health care fraud case ever prosecuted by the Department of Justice, as uncovered by Operation Gold Rush. The Organization, based in Russia and elsewhere, orchestrated a multi-billion-dollar health care fraud and money laundering scheme to target, exploit, and steal from Medicare and private health insurance companies.”

From the public health and medical / Rx research front,

  • The Washington Post reports,
    • “The CDC announced Monday that an American tested positive for Ebola this weekend while working in Congo and is being transported to Germany for treatment along with six other Americans who are high-risk contacts. 
    • “The Centers for Disease Control and Prevention also is enhancing public health screening and traveler monitoring amid a growing Ebola outbreak, and non-U.S. passport holders face entry restrictions if they have been to Uganda, the Democratic Republic of Congo or South Sudan in the previous 21 days.
    • “To the American public, the risk to the United States remains low,” said Satish Pillai, CDC Ebola response incident manager. “Travelers to the region should avoid contact with sick people, report symptoms immediately, and follow our travel guidance.”
  • Health Exec points out,
    • “A healthcare research firm that provides trend analysis to stakeholders released a new report that examined usage of behavioral health services post-COVID, showing that demand and utilization for mental healthcare and addiction mitigation have intensified since the pandemic.
    • “According to the data from Trilliant Health, while the utilization of care related to emotional health, mental health, autism, and alcohol and drug dependency stand at new highs since the COVID lockdowns, outcomes may not be improving.
    • “Using publicly available data on utilization, provider numbers and demand, Trilliant’s data paints a picture of a mental healthcare system that is overburdened. From 2018 to 2024, the group reports that the number of behavioral health visits jumped 62.6%, standing at 1,346 visits per 1,000 people.
    • “People seeking care for anxiety led the trend, accounting for 89.3% of growth. Women aged 18-44 made up the majority of that cohort. However, Trilliant noted that childhood developmental disorders—autism, attention deficit disorder, speech problems and other issues including anxiety—including attempted self-harm, have risen nearly 48% over 20 years, from 2004-2024.”
  • Health Day adds,
    • Many older adults see cannabis as a more effective or nonpharmaceutical option to manage sleep, pain, or mental health, according to a study published online May 8 in JAMA Network Open.
    • Rebecca K. Delaney, Ph.D., from the University of Utah Intermountain Health Department of Population Health Sciences in Salt Lake City, and colleagues explored the motivations of older adults in Colorado interested in purchasing edible cannabis products to improve sleep, pain, or mental health concerns, as well as the perceived benefits and drawbacks of different cannabinoid profiles. The analysis included 169 interview participants aged 60 years and older.
  • The New York Times relates,
    • “A study of insurance claims for 1.8 million children found that the number of families raising mental health issues at visits to general practitioners rose sharply over a decade, with anxiety by far the fastest-growing complaint.
    • “The study, which was published on Monday in the journal JAMA Network Open, found that the number of pediatric visits rose to 9.7 percent in 2023 from 5.7 percent in 2014.
    • “The study included all insurance claims for children from ages 1 to 18 in Massachusetts, for a total of more than 1.8 million children. Visits were counted as mental health visits if a diagnostic code was included in the claim, either because the child or the family raised the issue or because the child screened positive for mental health symptoms during the visit.
    • “Visits for anxiety rose by more than 250 percent during that period, to 6.1 percent in 2023 from 1.7 percent in 2014.”
  • The American Medical Association lets us know “nine things patients should know about taking creatine.”
    • “The ‘Health vs. Hype’ AMA podcast explores what creatine is, its association with bodybuilders, and whether it’s safe for the general public.”
  • Medpage Today tells us,
    • “A course of azithromycin for preschoolers who presented to the emergency department (ED) with wheezing didn’t improve their symptoms, the AZ-SWED trial showed.
    • :Among children, ages 18-59 months, the 5-day sum of scores on the Asthma Flare-up Diary for Young Children (ADYC) did not differ significantly compared with placebo in either those who initially tested positive for pathogenic bacteria (median 9.59 vs 9.72, P=0.70) or those who tested negative (9.30 vs 9.10, P=0.69). ADYC scores range from 5-35 points, with higher scores indicating more severe symptoms.
    • “While the trial was stopped early for futility — reducing the statistical power of the trial — it was sufficient to show that “a moderate or large true effect is implausible,” Richard M. Ruddy, MD, of the University of Cincinnati College of Medicine, reported at the American Thoracic Societyannual meeting in Orlando. The findings were published simultaneously in the New England Journal of Medicine.”
  • and
    • “The 2025/2026 seasonal COVID vaccination was associated with a roughly 50% reduced risk for illness up to 9 weeks post-vaccination, especially in older Canadian adults, according to an interim analysis by the Canadian Sentinel Practitioner Surveillance Network. The seasonal vaccine, which was specifically formulated to target the LP.8.1 variant, also appeared to offer protection from other strains.
    • “An important aspect of the 2025/2026 season was the simultaneous circulation of influenza and other respiratory viruses, which suggested the need to consider the role that respiratory virus co-circulation might play in estimating vaccine effectiveness (VE).
    • “This year, we were especially interested to check the effects of co-circulating respiratory viruses (eg, influenza and respiratory syncytial virus [RSV]) since COVID circulated at only low levels through the current season,” lead author Danuta M. Skowronski, MD, epidemiology lead for influenza and emerging respiratory pathogens at the BC Centre for Disease Control in Vancouver, told Medscape News Canada.”
  • The American Journal of Managed Care points out,
    • “A retrospective VA cohort (2006–2019) compared ≥75-year-olds with adenoma vs no adenoma at ages 65–75 using registry and National Death Index outcomes. 
    • “Ten-year CRC incidence and CRC death were statistically higher with prior adenoma, but absolute differences were small and clinically overshadowed by competing non-CRC mortality. 
    • “Frailty stratification showed progressively lower CRC incidence and sharply higher non-CRC death, with severe frailty demonstrating <1% CRC versus 82% non-CRC death. 
    • “Advanced adenoma status did not significantly alter CRC risk, and follow-up colonoscopy rates after 75 were not higher among patients later developing CRC. 
    • “Generalizability is limited by a 98% male veteran population, reinforcing the need for confirmatory analyses in cohorts with greater female representation.”
  • Per BioPharma Dive
    • “An experimental cancer immunotherapy from Regeneron failed a late-stage study in melanoma in a surprise setback for the big biotechnology company’s oncology business.
    • “A regimen involving the prospect, fianlimab, and Regeneron’s marketed medicine Libtayo didn’t significantly delay cancer progression compared to Merck & Co.’s Keytruda in patients with unresectable metastatic melanoma. A high-dose combination held tumors in check for a median of 11.5 months, compared to 6.4 months for Keytruda recipients, a difference that narrowly missed statistical significance.
    • “Regeneron didn’t provide additional details but will present them at a future medical meeting. Another Phase 3 study testing fianlimab against Opdualag, a similar cancer immunotherapy sold by Bristol Myers Squibb, is ongoing. Company shares fell by double digits early Monday, erasing billions of dollars in market value.”

From the U.S. healthcare business front

  • Kauffman Hall reports,
    • Key Takeaways
      • March was the best month for hospitals in 2026 so far, despite mixed volumes. Month-over month discharges rose while patient days fell, indicating increased focus on improving average length of stay and a continued shift to outpatient care.
      • Operating margins improved month-over-month but remain below 2025. While bad debt and charity care declined month-over-month, gross revenue continues to outpace net, highlighting eroding payor mix.
      • Expenses declined in March, yet remain elevated year-over-year. Favorable improvements across the board are likely correlated to the decrease in average length of stay. However, drug expenses remain a primary driver of expense growth year-to-date.
      • Two notable outliers emerged in otherwise steady regional trends. The Northeast saw margin improvement, despite historical underperformance, while the West experienced the most dramatic increase in drug expense.
    • To view more insights on trends affecting hospitals and steps you can consider taking to address them, download the latest issue of the National Hospital Flash Report.
  • Beckers Payer Issues notes,
    • “Blue Cross and Blue Shield of Massachusetts reported a net income of $59.6 million in the first quarter of 2026, a return to profitability after back-to-back annual losses in 2024 and 2025.
    • “The insurer posted revenue of $2.6 billion in the first quarter, reflecting a 2% net margin. Operating and other income came in at $17.4 million (0.6% operating margin), with investment income contributing $42.2 million.
    • “The company attributed the improved results to disciplined cost management, a milder-than-expected flu season and changes to its coverage of GLP-1 medications.
    • “Our first-quarter results reflect the challenging but necessary actions we’ve taken over the past year, including pricing our benefit plans to their true cost, identifying medical and pharmacy spending that doesn’t add value for our members, and keeping rate increases to our provider network at or below the state benchmark,” CFO Ruby Kam said May 15.”
  • Fierce Healthcare relates,
    • “Now three quarters into its fiscal year, Ascension has chopped down its operating losses by more than half and more than tripled its bottom-line gain. 
    • “The nonprofit system reported Friday a $203 million operating loss (-1.1% operating margin) for the nine months ended March 31, 2026, improving on the $466 million operating loss (-2.3%) for the prior fiscal year. 
    • “Both its total operating revenue and operating expenses dipped from the prior year due to a slew of divestitures. The former declined by 7.2% to $18.1 billion while the latter fell by 8.1% to $18.3 billion; on a same-facility basis, total operating revenue grew 9.3% while expenses increased 5.7%.” 
  • Healthcare IT News explains “How one practice combines in-clinic, telehealth and in-home care.”
    • “Dr. Payam Zamani is a practicing family medicine physician and founder and CEO of My Dr Now, one of the largest primary care providers in the Southwest. It’s designed as a hybrid in-person/telehealth/in-home health system.”
    • “When patients engage earlier and follow through consistently, the health system operates more efficiently, My Dr Now’s physician CEO reports: “This is not about technology for its own sake, it’s about designing care delivery around real life.”
  • Modern Healthcare tells us,
    • “Oregon gave the green light for Compassus to acquire a 50% stake in Providence’s home health and hospice operations across the state.
    • “After more than a year of review, Oregon Health Authority’s Health Care Market Oversight program said in a Friday news release it approved the joint venture with conditions.
    • “The Oregon deal is expected to close in the fall, Providence said in an email.”
  • and
    • “RWJBarnabas Health has opened a $7 million food-is-medicine hub to take on chronic disease, making it a potential standard bearer in the Make America Healthy Again movement.
    • “Last week, the New Jersey academic health system opened Harvest — an 8,000-square-foot facility in Newark that is a combination food bank, commercial kitchen and classroom. The center is designed to teach people living in nearby food deserts how to eat healthier and provide them with the food to do it.”
  • Health System CIO informs us,
    • “Epic added 77 acute care hospitals in 2025 while Oracle Health shed 56, according to the new KLAS report, “US Acute Care EHR Market Share 2026.” The five-year picture is even starker. Epic has gained a net 568 hospitals since 2021 while Oracle Health has lost 173. In total, the report covers EHR contracts executed from January through December 2025. Epic now holds 43.7% of acute care hospital market share and 56.9% of beds. Oracle Health, meanwhile, sits second at 21.9% of hospitals and 20.4% of beds, followed by Meditech at 14.7% and 12.5%.” * * *
    • “Hospitals impacted by EHR decisions fell about 40% from 2024 as buyers shifted investment toward AI and operational efficiency tools.”
  • Per MedTech Dive,
    • “Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.
    • “The agreement gives Boston Scientific an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain clinical and regulatory milestones. Boston Scientific said it may opt to acquire the rest of the TAVR business for additional cash payments totaling $3 billion.
    • “The deal comes about a year after Boston Scientific stopped selling its Acurate Neo2 and Acurate Prime TAVR devices, which were CE-marked in Europe, and ended plans to pursue approvals in the U.S. and other locations.”

Weekend update

David Ermer–CMS, Congress, Federal employment benefits, Medicare, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Roll Call offers an overview of this week’s anticipated activities on Capitol Hill.
  • STAT News reports,
    • “Bill Cassidy, a key Republican health care leader in the Senate, will lose his seat, as Louisiana’s Senate primary heads for a runoff between state treasurer John Fleming and Rep. Julia Letlow, who won President Trump’s endorsement.” * * *
    • “Cassidy’s defeat is a win for President Trump and his allies, who have criticized the senator for voting in 2021 to convict the president for inciting the January 6 insurrection.” * * *
    • “Cassidy will likely remain chair of his committee until his term ends at the start of next year, potentially setting up roadblocks for Kennedy as he attempts to fill several vacancies across his department. That includes a new Food and Drug Administration commissioner, and nominees for surgeon general and Centers for Disease Control and Prevention director.”
  • Federal News Network points out four benefits bills in Congress for federal employees, retirees to watch. “Potential adjustments to short-term disability insurance and credit protection for feds during government shutdowns are on the table through new legislation.
  • Per a May 15, 2026, Centers for Medicare and Medicaid news release,
    • “The Centers for Medicare & Medicaid Services (CMS) issued a sweeping rule to strengthen oversight of the Affordable Care Act (ACA) Exchanges for plan year 2027 by lowering user fees, tightening eligibility verification, and giving states greater authority over plan oversight.
    • The final rule, “Notice of Benefit and Payment Parameters for 2027; Basic Health Program” (the 2027 Payment Notice final rule) reduces federal Exchange user fees to help lower premiums, establishes new safeguards to prevent improper enrollments, ensures subsidies go only to eligible individuals, increases consumer choice, affordability, access and protections, and expands state flexibility to manage Exchange operations.
    • “The rule strengthens program integrity, expands consumer protections, promotes plan innovation and consumer choice, and restores greater authority to states. 
    • “American taxpayers deserve to know their dollars are going only to people who truly qualify,” said CMS Administrator Dr. Mehmet Oz. “This rule strengthens eligibility checks, cracks down on abuse, and gives insurers more flexibility to offer affordable, consumer-focused coverage options.”
  • Here is a link to the CMS fact sheet on this final rule.
  • Kevin Moss writes in Govexec,
    • “CMS is launching the Medicare GLP-1 Bridge program, which will extend coverage of certain GLP-1 medications for weight loss to eligible Medicare beneficiaries, regardless of whether they have an underlying medical condition” effective July 1, 2026. 
    • “For [FEHB and PSHB} annuitants enrolled in Part D, this program could expand your options. Here’s [in the article] what it covers, who qualifies, and what it means for you.”
  • The U.S. Supreme Court will be releasing opinions at 10 am every Thursday morning until the end of next month.

From the public health and medical / Rx research front

  • The Wall Street Journal considers whether “the Weight-Loss Drug Revolution Causing a Frailty Epidemic? As millions flock to GLP-1s, doctors warn the drugs can cause rapid and significant muscle loss” and assesses “What Science Tells Us About the Risks of Hantavirus. Rare virus has high fatality rate and can spread through the air, research shows, though it is easier to contain than Covid-19.”
  • Health Day reports,
    • “A major women’s health condition is getting a new name—and experts say it could change how millions are diagnosed and treated worldwide.
    • “Polycystic ovary syndrome, or PCOS, will now be known as polyendocrine metabolic ovarian syndrome, or PMOS.
    • “The condition affects more than 170 million women worldwide and is linked to hormone imbalances, weight and metabolic issues, mental health symptoms, skin changes and fertility challenges.
    • “Experts said the old name was misleading because the condition is not actually defined by ovarian cysts.
    • “What we now know is that there is actually no increase in abnormal cysts on the ovary and the diverse features of the condition were often unappreciated,” said Helena Teede, director of the Monash Center for Health Research & Implementation in Australia and an endocrinologist at Monash Health.”
  • BioPharma Dive relates,
    • “A year after Vertex’s big launch, pain drug research faces a pivotal moment.
    • “Journavx started to revive area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?”

From the U.S. healthcare business and artificial intelligence front,

  • The Wall Street Journal reports,
    • “Nurse practitioners and physician assistants are increasingly filling healthcare gaps, with NP ranks growing 60% to 461,000 between 2019 and 2025.
    • “Doctors’ groups express concern that non-MD providers practicing without physician oversight may pose risks to patients.
    • “A 2023 study found that allowing nurse practitioners to work without physician supervision reduced deaths that could have been prevented through healthcare by 2%”
  • Fierce Healthcare relates,
    • “Even without counting the multi-billion hit tied to the early termination of a major joint venture and outsourcing arrangement, CommonSpirit Health’s operations took a bruising during the three months ended March 31.
    • “The major Catholic nonprofit system reported Friday a $578 million operating loss (-5.8% operating margin) during the third quarter of its fiscal year. That’s after two key adjustments: normalization for delayed income received through California’s provider fee program; and removing the nearly $2.5 billion of “special charges” the system recorded on paper for the quarter that include contract termination and intangible asset impairment stemming from its breakup with Tenet Healthcare’s revenue cycle services business. 
    • “For comparison, CommonSpirit had logged an $85 million operating loss (-0.9% operating margin) a year prior with the California provider fee program adjustment. Across the first nine months of the fiscal year, the system is looking at a $743 million operating loss (-2.4% operating margin) for 2026 and a $282 million operating loss (-1.0% operating margin) in 2025, with the same adjustments.” 
  • Health Exec tells us,
    • “The days when most doctors worked in independent practice settings are fading from memory like old photoprints in a musty scrapbook.
    • “Taking their place is an era dominated by physician employment. And the employers are not only hospitals but also a “vast array of corporate entities with various financial incentives for employing physicians.”
    • “The quote is from the authors of a new report compiled by Avalere Health for the Physicians Advocacy Institute, also known as PAI.
    • “The shift towards corporatization of physician practice, the PAI analysts add, has “significant implications for costs, patient care and the future practice of medicine.”
    • “The report looks at trends in practice acquisitions as well as physician employment over the eight-year stretch from January 2018 to January 2026.”
  • MedCity News informs us,
    • “Anomaly Insights, an AI-powered payer intelligence company, announcedWednesday that it raised $17 million in funding.
    • “The company’s platform analyzes healthcare transactions to identify payer behavior patterns, policy changes and adjudication deviations. It helps predict at-risk payments so providers can proactively ensure claims are paid accurately. It also detects new denial patterns and identifies revenue opportunities. Currently, Anomaly is being used across more than 20 health systems.
    • “Specifically, the company seeks to solve the issue of “not knowing whether a healthcare encounter will be paid for or not before it happens,” said Mike Desjadon, CEO of Anomaly.”